Essence and content of the quality management system, structure and requirements for it. Characteristics and activities of JV "Frebor", 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 industrialwflax enterprise(For examplejoint venture « Frebor»)

Introduction

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

However, over time, to maintain their competitive status, organizations no longer had enough evidence that the production process they organized was capable of providing the agreed level of quality. This was facilitated by the further toughening 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 the quality methodology covers not only the problems of product and service quality, but also the quality of management itself, which is directly responsible for the process of forming the appropriate level of product quality.

The consequence of this are the widely used quality management systems (QMS), which, as a rule, become the control subsystem of any production, covering all stages of the enterprise.

Improving the quality of manufactured 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 the 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. Raising the technical level and quality of products determines the pace of scientific and technological progress and the growth of production efficiency in general, has a significant impact on the intensification of the economy, the competitiveness of domestic goods and the standard of living of the country's population.

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

An increase in the production of high-quality products by Belarusian enterprises should ultimately lead to the 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 it is necessary to learn how to more effectively use economic, organizational and legal levers of influence on the process of formation, 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 a set of properties and characteristics of a product or service that gives it the ability to satisfy stipulated or implied needs (ISO standard 8402 - 94). 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 high-tech products and high-quality consumer goods is the main sign of a full-blooded, prosperous economy.

Today the world uses various systems quality management. But to be successful at present, they must ensure that eight key principles can be implemented. system management quality mastered by leading international companies. These principles form the basis of the ISO 9000 series of international quality management standards.

It must be understood that the modern concept of quality management is the concept of managing any purposeful type of activity, which, as experience shows, allows achieving success not only in the field of 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 theme of the graduation project "Improving the quality management system at an industrial enterprise (on the example of JV Frebor)" was chosen.

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

Object of studythesiswork is a joint venture Frebor.

Subject of study- enterprise quality management system.

aimthesis 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.

The structure and requirements for the quality management system.

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

Give a description of the object under study.

Analyze the organizational structure of the enterprise management.

Analyze the organizational structure of the quality control department.

Conduct an analysis of the feasibility and financial indicators enterprise activities.

Analyze the quality management system of the enterprise.

Develop measures to improve the quality management system.

Develop constructive and technological measures.

Consider how 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 income statement for 2006, 2007 and 2008, the enterprise's charter, textbooks, publications in journals, and the work of domestic and foreign economists.

1. Quality management system

1.1 The essence and content of the quality management system.Building approachesniyu QMS

Already in the late 60s, scientists and specialists in many countries came to the conclusion that quality cannot be guaranteed only through control 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, when selling products, maintenance during operation at the consumer and disposal after use.

Such A complex approach ensures the creation of a closed process that begins with the definition of market needs and includes all phases of product improvement or development, production preparation, manufacturing, sales and after-sales service based on an effective system " feedback» and market-driven planning with minimum quality assurance costs.

The set of organizational and technical measures necessary for

providing the consumer with guarantees of a consistently high quality product, its compliance with the requirements of standards and the contract is called quality system.

Quality management is understood as a set of principles, techniques, means and methods for implementing the functions of managing the processes of ensuring and improving the quality parameters of the corresponding object or system.

A quality management system (QMS) is a management system for directing and controlling an organization with regard 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 should 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 examinations;

Packaging and storage;

Implementation and distribution;

Installation and operation;

Technical assistance and service;

ISO - international organization for standardization, world federation national organizations on standardization (committees - members of ISO). The goal of ISO is to develop the principles of standardization and design standards based on them that promote integration processes in various fields and activities.

The principle behind the development of ISO standards is quite simple. The initiative to create new standards comes from the organizations that use the standards (as a rule, these are manufacturers of products or services that need to be integrated with other products or services). These organizations form the basic requirements for the standard and pass them on to their national (by country) representatives in ISO. ISO decides on the advisability of developing new standards, and after a positive decision, a technical committee is determined to develop a draft standard. The draft standard is circulated to ISO member committees for study and evaluation. After a positive vote, it is accepted as an ISO standard.

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

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.

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

- Orientation of the organization to the consumer;

– the role of management in integrating management objectives and internal environment organizations;

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

– approach to management as a process;

– a systematic approach to management;

- continuous improvement as the goal of the organization;

– method of decision-making based on facts;

- Mutually beneficial relationships with suppliers.

Consider their content.

ORandenation on the consumer. The application of the principle of customer orientation is an activity aimed at studying and understanding all the needs and expectations of consumers, including requirements for quality, packaging, delivery time, price, services, etc.; studying the needs of other stakeholders (owners, shareholders, personnel, suppliers, the state, the region and society as a whole); ensuring awareness and optimization of the balance of all requirements, needs and expectations of all interested parties and their documentation; ensuring that the goals and objectives of the organization meet the needs and expectations of consumers; reflection of the principle of customer orientation in the Quality Manual, policy, goals of the organization.

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

The application of the principle of leader 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 by personal example;

Understanding and responding to external changes;

Consideration of the needs of all interested parties, including consumers, owners, personnel, suppliers, society as a whole;

Forecasting the future of the organization;

Setting long-term strategic goals and objectives;

Creation and maintenance of 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 of action with the required responsibility and accountability;

Initiating, encouraging and recognizing the contribution of employees;

Training and promotion of people;

Maintain open and honest relationships.

ATemployee engagement. 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.

The 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 the responsibility of each for the results of their activities;

- defining the role and responsibility of personnel, involving them in solving problems;

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

– involvement of personnel in the assessment own indicators in comparison with their personal goals and objectives;

- involvement of personnel in the active search for opportunities to improve their competence, knowledge and experience;

– creation of conditions for free exchange of knowledge and experience.

All personnel of the enterprise - from top management to workers - should be involved in quality management activities.

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

- to determine the processes necessary for the release of products;

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

– establishing clear responsibilities and authorities for process management;

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

– definition of criteria for measurement and analysis of processes;

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

- determination of methods for ensuring the effectiveness and efficiency of the implementation of processes;

- determination of the relationship 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;

– assessment of risks, consequences and impact of processes on customers, suppliers and other interested parties.

The essence of the process approach is that the performance of each work is considered as a process, and the functioning of the organization - as a chain of interrelated 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, determined common goal;

- visibility and understandability for the personnel of activities at the enterprise;

- 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 and their consistency;

Measurability of results by numerical characteristics;

Facilitate the management of the organization;

Bringing people together and strengthening teamwork, motivation of personnel to achieve the goals of the processes and the organization.

With this approach, it becomes possible to exercise control over the use of each type of resource, to analyze and search for opportunities to reduce the cost of producing products and providing services.

With the transition to a process approach, activities to assess the risks, consequences and impact of processes on consumers and other stakeholders acquire concreteness, significance and a close relationship between the invested resources and the results obtained.

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

Figure 1.1 - Quality management system model based on the process approach

Withsystems approach to management. Defining, understanding and managing a system of interrelated processes improves the effectiveness and efficiency of an organization .

Application of the principle systems approach to management is the implementation in the organization of activities aimed at:

- on structuring the system by establishing and developing a system of processes that ensure the achievement of the specified goals of the organization;

- creation of such a system in which the set 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 the goals;

– continuous improvement of the system through measurement and evaluation;

- identifying opportunities and resources first, and then making decisions about action.

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

Ppermanent improvement. The application of the principle of continuous improvement is the implementation of activities at the enterprise aimed at:

to set goals for managing and measuring continual improvement;

– evaluation, recognition and validation of improvements;

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

- providing employees with the opportunity to learn methods and means of continuous improvement;

- the formation of the need for each employee of the enterprise in the continuous improvement of products, processes and the system as a whole, the motivation of the personnel involved in the improvements;

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

– continuous 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 the organization of activities aimed at:

Organization of monitoring, measurements, data and information collection;

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

Use of proven methods for data and information analysis;

Understanding the value and application of appropriate statistical methods for the analysis and processing of information;

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

Making data available to those who need it.

ATmutually beneficial relationships with suppliers. The organization and suppliers are interdependent and their mutually beneficial relationship enhances their ability to create value. The application of the principle of mutually beneficial relations with suppliers is the implementation in the organization of activities aimed at:

– identification and selection of key suppliers;

- establishing relationships that balance short-term benefits with 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 supplier improvements and achievements;

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

– joint work by a clear understanding of the needs of the consumer;

– development joint action for improvement;

– exchange of information and plans for the future.

The main purpose of this principle is to change the strategy of the enterprise 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 a quality management system

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

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

Process - a set of interrelated and interacting elements of activity that transform "inputs" into "outputs". In this case, the "inputs" of the process are usually the "outputs" of other processes. Processes in an organization are typically planned and executed with the goal of adding value (from "input" to "output").

The concept of procedure is of great importance 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 the appropriate medium. The main QMS documents are listed in the box. Other organizational and administrative documents of the enterprise, for example, “Regulations on subdivisions” and “Job instructions”, should be associated with the documents of the quality system.

Quality management system documents:

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

- quality policy - the main directions and goals of the organization in the field of quality, formally 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;

ISO 9001:2000 “Quality management systems. Requirements” establishes the basic requirements for a quality management system (quality system), but does not explain how these requirements can be met. This allows the use of this standard in organizations that carry out various activities, and take into account, in its observance, the characteristics of each organization.

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

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

- Quality Management System;

- management responsibility;

- resource management;

- processes of product life cycle;

- measurement, analysis and improvement;

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

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

— define the processes needed for the quality management system and their application throughout the organization;

- determine the sequence and interaction of these processes;

- define 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;

- to monitor, measure and analyze these processes;

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

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

- making documented commitments of the organization in the form of policies and objectives in the field of quality;

- analysis of the quality system;

- providing the quality system with the necessary resources;

- organizing the work of personnel to create and successfully operate the quality system of the organization, the distribution of responsibility and authority of employees in the field of quality.

- The input to the management review should include the following information:

- results of audits;

- evaluation of products by consumers;

- evaluation of the functioning of processes and product quality;

- composition and results of preventive and corrective actions;

- the effectiveness of the measures taken as a result of the previous management review;

— changes that could affect the quality system;

Resource management. The organization must determine and ensure necessary resources to achieve their goals and objectives, including in the field of quality and fulfillment of consumer requirements. This refers to all types of resources - human, infrastructure, work environment, financial resources. The ISO 9001:2000 standard pays the most attention to human resources, since the competence and attitude towards the work of the personnel mainly determine the quality of products. This standard requires an organization to:

- 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 the education, training, skills and experience of staff.

Product Life Cycle Processes. The product life cycle processes are also called business processes or core processes. Core processes are key to an organization because they add value to the product. Processes can be composed 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 objectives and product requirements;

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

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

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

- process owners, their responsibilities and authorities;

- the resources required to perform 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 that the processes are running correctly and confirm the quality of the product;

- criteria for making a decision on the correctness of the processes and the conformity of the products to the established requirements;

- methods, methods and forms for recording data that contain objective evidence that the processes are under control and the quality of the products meets the 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 the recommendations for improving the QMS, given in the ISO 9004:2000 standard. The essence of these recommendations is that all systems (in the processes of the organization) should be constantly measured, analyzed and improved. This should be done by the working teams of the processes, all team members under the guidance of the owners and with the overall coordination of the 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 given to the stage of research and development of products.There are the following comprehensive tools and quality improvement methodologies:

- collective work in teams;

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

- Deployment of the quality function (QFD-methodology);

- methodology of reengineering;

- benchmarking methodology;

- methodology "Six Sigma";

- methodology (methods, approaches) Genichi Taguchi;

- self-assessment methodology;

- problem solving methodology.

Activities in the quality management system, including quality improvement activities, are based on constant and sustainable cooperation between people, i.e. on effective teamwork. Teamwork is the engine (locomotive) of the quality management system.

There are a large number of options and styles for the collective work of organization 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 direction of his manager, for example, a foreman;

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

- to make recommendations to top management and managers of the organization on quality improvement issues.

Failure Mode and Effect Analysis (FMEA-methodology), also known as "Risk Analysis", is used as one of the preventive measures for systematic detection of causes, probable consequences. The FMEA methodology is commonly used in the work of cross-functional teams to analyze the forms and consequences of product and process failures, however, there are examples of successful application of this methodology in quality circles.

Quality Function Deployment (QFD)

it is a methodology for the systematic and structured transformation of customer wishes into quality requirements for a product, service and/or process.

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

- increase in added value;

- improving the 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 concept of Six Sigma is based on the fact that there is a direct correlation between the number of product defects, the increase in 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 indicates 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 management systems for commercial, administrative and economic activity enterprises. The provision of the enterprise with such management systems, taking into account industry specifics, makes it possible to increase the economic efficiency of production, contributes to its rationalization, provides an opportunity to quickly obtain production and economic data for successful planning and management of production processes.

Automation of enterprise QMS processes allows:

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

– to ensure the planned interaction of all structural divisions of the organization (with control of deadlines) in the performance of pre-project and design work;

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

- organize an effective redistribution of work between performers if it is necessary to replace them (illness, production necessity, etc.);

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

- organization of the work of performers, providing a list of work to be performed, a reminder of current and overdue work, control of 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-Dializotekhnik is a limited liability company.

Figure 2.1 - Location of the Frebor Joint Venture

The joint venture "Frebor" was established on December 29, 1988 with the participation of the USSR Ministry of Biomedical Industry between three parties: the Borisov Plant of Medical Preparations, the East German company "Fresenius" and the Joint-Stock Company "Pharmindustriya" (Russia). Production activity started in 1992.

The history of the company dates back to 1988. On the territory of the former USSR there was no such production of dialyzers ("artificial kidney"), despite the huge number of patients who needed 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 establish a joint venture in Borisov.

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

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

When JV Frebor was established in 1988, Fresenius transferred Newest technologies production of polysulfone dialyzers and, in particular, the "know-how" of the technology for the production of a unique polysulfone fiber, as a contribution to its authorized capital.

The founders of the enterprise are:

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

RUE "Borisov Plant of Medicinal Products" - 78.2% of the shares, on its basis the production facilities of the joint venture in Borisov were created.

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 Fresenius Medical Care on the establishment of a joint venture.

1992 - Commissioning.

1993 - Start of production of transfusion-infusion systems UMS

1994 - Launch of the polysulfone fiber line

1995 - TUV International 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 to 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 site for the assembly of 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 - Obtaining a diploma "The best entrepreneur of 2006 in the field of medical activity"

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 phase (1992), machines for the production of polysulfone membranes were installed.

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

The main activity of JV "Frebor" 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 (blood transfusion systems UMS-1-1, devices for taking blood from donors, sets of lines for homesorption (blood purification by segments), conductors and infusion lines (for syringe dispensers and infusion pumps), etc.).

Production area for main as well as auxiliary production, storage, administrative and amenity and a number of other premises are leased from state enterprise"Borisov Plant of Medical Preparations".

On the leased premises, an efficiently functioning, unique in terms of applied technology production of disposable medical products for the treatment of renal 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 manufacturing universal medical transfusion-infusion systems UMS and other import-substituting products was introduced. , the release of which currently fully covers the needs of healthcare in the Republic of Belarus. In 1994, the line for the production of polysulfone fibers, the main filter element of the capillary dialyzer, came into operation, and in 1997 the second line was launched.

The number of main products currently being manufactured is planned to increase in the future and produce, for example, dialyzers for one million pcs. more per year.

2.2 Characteristics of products and their markets

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

The technological process for the production of dialyzers 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, due to the porous structure of the fiber shells, substances harmful to the body - toxins are excreted through the pores of the fiber shell to the outside, and the patient's purified blood flows further and returns to the human body.

The basis of the dialyzer is polysulfone fiber, produced according to a special technology, which cleans the blood from toxins as it flows through the dialyzer.

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

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

In the preparatory part, the preparation of the spinning mass is carried out, ensuring its uniformity. The fibers are formed in a system of nozzles and sent through the washing and spinning 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 certain number of fibers depending on the type of fiber bundle. The bundles are wrapped in a special film and placed in cardboard boxes. Cartons with 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 fed to the dialyzer assembly area.

Together with the 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 are physically easier to perceive them and feel more comfortable when using them.

High permeability, exceptional biocompatibility, minimum 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 everywhere discontinued cuprofane plate dialyzers. These advantages make dialyzers a unique product that not only meets the ISO 9002 global quality standard, but is 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 diseased kidneys.

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

During its production activity, JV Frebor has achieved a significant increase in production volumes. Using a careful selection of working personnel and training them in the necessary production skills, the introduction of a three-shift mode of operation, an increase in the rhythm of production, it was possible to achieve volumes that exceeded the originally planned average by 20%.

Currently, the technological structure of JV Frebor can be divided into four main types of production: the production of dialyzers, the production of blood lines, the production of fibers and the production of infusion systems. The scheme of the relationship of industries is shown in Figure 2.2.

Figure 2.2 - Scheme of the relationship of production

Thus, JV "Frebor" is an enterprise that produces high-tech, socially important products. The field of marketing decisions of the company 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 this product 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. At the same time, each of the patients must visit the hemodialysis center approximately three times a week, which requires about 150 dialyzers per patient per year. Thus, the total need of the republic is up to 300,000 dialysis kits per year.

According to rough estimates, more than 10 million dialyzers are required annually to meet the needs of the CIS countries. These studies on the needs of dialyzers were carried out previously 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 lines for the production of dialyzers at Fresenius (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 sales markets for JV Frebor products shows that no more than 6% of the total volume of finished products is supplied to the domestic market of the Republic of Belarus. The main consumers of medical products are, first of all, medical institutions, system of the Ministry of Health.

Figure 2.2 - Structure of sales of JV Frebor products

Finished products are released to enterprises various forms ownership of Borisovskoe PO « Screen", « Oblkoopnigtorg, Minsk, LLC « Envoy, Borisov, LLC « Panacea, etc. The share of deliveries to these enterprises is 4%.

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

2.3 Analysis of the organizational structure of the management of JV Frebor

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

The supreme body of the enterprise is General meeting 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 enterprises, establishes the procedure for the distribution net profit, decides to release valuable papers 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 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 deputies appointed by him, heads of departments of the management apparatus, workshops, departments, sections, etc., as well as foremen.

The technical director of the plant pursues a technical policy, determines the main directions in the field of product design and technology, develops promising directions for the development of the enterprise, coordinates research and development work to introduce new equipment and technology.

Commercial Director leads and implements a marketing and sales policy aimed at solving the problems of accelerated sales of products, by studying the market and adapting to it, production, develops 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 the sale of products; manages the department of labor organization and wages and the personnel department; is responsible for coordinating the work of both production sites and other departments of JV Frebor, 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 JV Frebor and the implementation of tasks in accordance with ISO 9001, ISO 13485 and ISO 14001 for the enterprise.

The Deputy Director for General Issues leads the work on the timely provision of the main and auxiliary production with material resources, the work of the transport service of the plant.

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 economic and economic issues provided for by the charter of the enterprise.

The planning and economic department develops annual, quarterly plans for the enterprise and individual workshops, monitors their implementation, determines ways to eliminate shortcomings, 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 of the main units, workshops and factories, develops and submits for approval projects, prices for new products, studies and implements best practices in organizing planning and economic work, etc.

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Since the production powers and duties of BUK employees are not regulated at the JSC Geomash enterprise, it is necessary to develop a job description for this unit.

The job description is developed by the head of the department for his immediate subordinates.

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

The first copy of the job description for each employee is stored in the personnel department, the second - with the head of the unit, the third - with 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 unit and evenly distribute the workload among employees, taking into account their level of qualification.

Each job description contains an unambiguous definition of what this work different from all other works. Responsibility for the completeness of providing the organization with job descriptions lies with the head of the personnel department.

Also, for the employees of the enterprise, it is necessary to develop a responsibility matrix that will allow you to determine who within the organization is related to a particular process, as well as to determine those responsible for the process.

Table 2 - Responsibility distribution matrix in the quality management system of JSC "Geomash"

	Process name	Responsible persons
General Director of JSC "Geomash"	Head of BUK	Head of Quality Control Department	Head of the FSO	Chief technologist
	Document management of the quality management system
	QMS analysis by management
	The procedure for providing the enterprise with personnel of the required qualification
	Personnel training
	The procedure for maintaining technological equipment in working condition
	The order and organization of the manufacture of technological equipment and tools, the provision of production with them
	Providing the enterprise with energy resources
	Technical information management
	The procedure for the development, execution, approval, approval and analysis of the technical and industrial financial plan
	The procedure for the development, coordination and approval of the plan of organizational and technical measures
	Registration procedure additional agreement for the manufacture of products
	Procedure for the development of technological processes
	The procedure for the development, approval, approval of design documentation
	Analysis, evaluation and supplier selection
	The order of input control of materials, raw materials, semi-finished products and components
	Release planning and ensuring operational management of product release
	The order of control and testing of products in the production process
	Management of measuring instruments and test equipment
	Internal audits
	Management of nonconforming products during the production process
	After-sales service for products
	Corrective and preventive actions
Note: O - responsible; I- is informed; Y- Member

The policy of JSC "Geomash" in the field of quality is aimed at quality performance 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 a direct movement towards a specific goal.

Geomash JSC needs to pursue a differentiation strategy due to the diverse preferences of customers. Competitive advantage organizations will be all the more tangible.

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

• - consumer orientation;
• - leader leadership;
• - involvement of employees;
• - continuous improvement;
• - Mutually beneficial relationships with suppliers.

Based on this, it is necessary to develop the objectives of the senior management for the prospects and appoint a responsible one. Quality objectives should be measurable and consistent with the quality policy. The goals of top management in the field of quality for 2016 are presented in table 3.

Table 3? Top management quality goals for 2016

prospects		Indicators	Criteria	Responsible executor
Financial		Energy Saving	RUB 2,690 thousand	Chief Engineer
Market	New Product	Creation of new types of drilling equipment	In accordance with the R&D plan for 2016	Chief Engineer
Processes	Reducing production costs	Reducing labor intensity, reducing the production cycle of manufacturing products through the introduction of design and technological solutions	Saving 1300 thousand rubles.	Chief Engineer
Financial		Reduced labor intensity due to the revision of time standards	Saving 480 thousand rubles.	Deputy gene. director of economics.
Financial
Processes		Reduction of terms of elimination of claims of consumers	Up to 8.5 days	Deputy gene. quality director
Financial		Reducing the cost of eliminating internal defects
Processes	Increasing the volume of marketable products	Growth in labor productivity		Deputy gene. production and logistics director
Procurement quality	The number of purchased products that meet the requirements of technical documentation	Not less than 92%	Deputy gene. production and logistics director
Increasing customer satisfaction	Increase in the number of orders made within the time agreed with the consumer		Deputy gene. production and logistics director
Processes	Introduction of new technologies in production processes	Reducing labor intensity, reducing the production cycle of manufacturing products through the introduction of new technologies	Saving 300 thousand rubles.	Deputy gene. development and modernization director
Financial		Decreased headcount at JSC Geomash
Processes	Providing the enterprise with personnel of the required qualification	Send employees to study at a foundry university		Assistant Gen. HR director

The management of the enterprise must ensure that:

• — the quality policy is consistent with the objectives of the organization;
• — include a commitment to meet 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 personnel of the enterprise and understandable to him;
• - analyzed for continued suitability.

The management of the enterprise must ensure that quality objectives are established in the relevant 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, evaluate the effectiveness and efficiency of the process.

The process map should represent the process to the extent necessary to obtain sustainable and acceptable process outcomes. It is not necessary to include in the process map all the details that qualified employees need to know themselves. Therefore, another purpose of the process map is to solve "interface problems" between the units involved in the process. The results of the work of one unit (or organizational unit) must be fully demanded by the subsequent unit, and these results must be sufficient to complete the work. The "outputs" from one unit must fully correspond to the "inputs" of another. To ensure such a “docking”, a process map is being developed. The map of the process "Management of the quality management system" of JSC "Geomash" is presented in Table 4.

Table 4 - Map of the process "Management of the quality management system"

Designation and name of the process	Quality management system management
Process status	Management process
P. GOST ISO 9001-2011	4.1 ;4.2; 5.2; 5.4; 5.5; 5.6; 8.2.2; 8.5
Purpose of the process	Continuous improvement of the enterprise QMS
Process manager	Head of Quality Control Department
Process participants	Process managers; Leaders structural divisions
Components of the process (main activities)	Planning for the functioning, improvement and management of the QMS; Management of enterprise QMS processes; Documentation and management of enterprise QMS documentation; Planning and documentation of... The plant must have and implement a rational system for collecting, accounting, processing, analyzing and storing information data on the quality of products for a certain period; To ensure the required quality of each type of product, the enterprise must have a separate product quality management system; - improvement of logistics should be carried out by the ability to find the right suppliers, increase the interest of each supplier and establish close contacts with them of a multifaceted nature; - management actions must be effective and carried out in relation to all stages of the product life cycle; - a product quality management system can be considered effective when the manufactured products meet the requirements of the consumer and the existence of an effective product quality management system is recognized by the consumer; - creation of a system of continuous training in the field of product quality management and education of all workers; - the product quality management system should be clear to everyone; - attracting a much wider range of workers to quality groups and increasing their activity and work efficiency; - expansion and implementation of a whole range of measures that ensure the implementation of the human factor in production and social relations; - the use of professionals in the field of product quality management in carrying out all work to improve the product quality management system. The output for management review should include the following information: - results of quality checks; - feedback from consumers; - operation of processes and conformity of products; — status of preventive and corrective actions; — follow-up actions arising from previous management reviews; — changes that could affect the quality management system; - recommendations for improvement. The output of the management review should include all decisions and actions related to: — improving the effectiveness of the quality management system and its processes; - improvement of products according to customer requirements; - Resource requirements. Conclusions for the chapter: in general, the implementation of all the proposed measures aimed at improving the quality management system at Geomash OJSC will improve the internal and external reliability of the enterprise, increase competitiveness, and improve product quality.

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The sustainable success of an organization is achieved through its ability to meet the needs and expectations of its customers and other interested parties in a sustainable and balanced manner. Sustained success can be achieved through the effective management of the organization, through the organization's awareness of its environment, through learning and the proper application of improvements and (or) innovations.

The introduction of a quality management system gives the enterprise: firstly, the movement of information flows at the enterprise is “put in order”, unified, identified, registered, using official regulations. This ensures that the products and accompanying documentation meet the requirements of consumers. Secondly, personnel are trained and trained. Thirdly, the documentation is easy to trace, and the output result becomes just as transparent. Fourthly, evidence of effectiveness is provided (documents confirming the compliance or non-compliance of products with consumer expectations), plans, intentions and, importantly, the consequences of decisions taken are reflected. This allows management to quickly adjust their actions - until all issues are closed. Fifthly, criteria for evaluating the selection of counterparties - suppliers and contractors are determined and the necessary documentation is developed. Sixthly, special checks are carried out - for compliance of the actual activity of the enterprise with the prescribed rules. Seventh and last, rules and methods for responding to both detected nonconformities and potential threats are developed and put into effect. Thus, the suitability and effectiveness of the quality management system in the enterprise is assessed regularly and continuously and, if necessary, is subject to adjustments.

For the successful functioning of the quality management system at the enterprise, one cannot stop at the achieved result, it is necessary to carry out permanent job to improve the functioning of the processes of the quality management system, improve the quality of products, services provided.

GOST R 9004:2010 was developed to be consistent with ISO 9001 and compatible with other management system standards. This standard provides guidance for organizations to achieve sustained success through a quality management approach. It is applicable to any organization, regardless of its size, type and type of activity.

Compared to ISO 9001, the objectives for customer satisfaction and product quality have been expanded to include the satisfaction of all interested parties and the performance of the organization as a whole.

This International Standard contains guidelines and recommendations. It is not intended for certification or use in contracts and regulations, nor for use as a guide to the implementation of GOST R ISO 9001. .

ISO 9004 encourages the use of self-assessment as an important tool for assessing an organization's maturity level, covering management leadership, strategy, management system, resources and processes, in order to identify strengths and weak sides, as well as opportunities for improvement and/or innovation.

ISO 9001 and ISO 9004 have been promoted as a pair of mutually agreed standards with a similar structure. ISO 9004 provides guidance on the development and continual improvement of quality management systems, and ISO 9001 is used to assess and set requirements for quality management systems. ISO 9004:2009 is now a different standard from ISO 9001. It is not a simple extension of ISO 9001. It has a different structure and scope. This is also reflected in the title of ISO 9004:2009 Management for the sustainable success of an organization. Approach based on quality management”.

The new edition of ISO 9004 is based on the belief that satisfied customers are the foundation of an organization's success. And to ensure sustainable success, an organization needs to go further and meet the needs and expectations of all stakeholders. This implies the application of quality management principles already to ensure the sustainable success of the organization. ISO 9004:2009 suggests that sustainable success can be achieved by the sound application of the eight quality management principles through active process management, including:

Regular monitoring and analysis of the organization's environment;

Determining the needs and expectations of stakeholders;

Establishing and maintaining a mission, vision and values ​​derived from the needs and expectations of stakeholders;

Clearly establishing, implementing and communicating strategies and policies to fulfill the mission and vision that support values;

Transformation overall strategy into specific goals and objectives, measured in specific indicators and set for specific individuals;

Identification, provision and management of internal and external resources necessary to achieve short-term and long-term goals;

Providing products that will consistently meet the needs and expectations of consumers and other interested parties;

Regular monitoring, measurement, analysis and review key indicators organizations;

Continuous improvement, innovation and learning.

The structure of ISO 9004 has undergone a major revision:

Section 4 on managing for the sustainable success of an organization is addressed to the business environment and stakeholders. Here, in practice, ISO 9004 and ISO 9001 have completely diverged, despite the fact that ISO 9001 contains changes regarding the business environment that affects the quality management system.

Section 5 on strategy and policy looks at the mission, vision, values, strategy and policies and some additions to demonstrate their interactions. Here, ISO 9004 moved away from the simple "management responsibility" of ISO 9001, making this clause more flexible, broader in application, and more in line with global best practices.

Clause 6 on resource management covers a broader scope than the corresponding clause of ISO 9001 to include additional resources: finance, knowledge, information, technology and natural resources. Thus, ISO 9004 considers all the resources actually needed to achieve product conformity.

Clause 7 on process management is more general than the equivalent clause of ISO 9001, Product release, and broader in scope. ISO 9004 process management is applicable to all processes in an organization, even including outsourced processes.

Clause 8 on monitoring, managing, reviewing and reviewing covers all clauses in clause 8 of ISO 9001, except for the items for continual improvement, which have been moved to a separate clause 9.

Clause 9 on improvement, innovation and learning relative to clause 8.5 of ISO 9001 added innovation and learning, two very important concepts for any organization to achieve sustained success.

The implementation, maintenance and development of the quality management system in accordance with the requirements of the International Standard ISO 9001:2008 largely contributes to the increase in the efficiency and competitiveness of the activities of OAO Nefteyuganskneftekhim. The introduction of a quality management system significantly increases the profitability and transparency of the enterprise - this simplifies the attraction of investments for modernization and development, clarifies the responsibility of each employee, his significance in the work on the overall result of OAO NKNK.

Availability of a certified quality management system joint-stock company gives a guarantee to consumers of products and services that all processes of the company are controlled and managed, products supplied to Russian and foreign markets are of quality in accordance with the requirements of international standards.

But it is impossible to determine the limit of development of the quality management system - after all, as they say, "there is no limit to perfection."

For further effective work and development of the joint-stock company " Nefteyuganskneftekhim” needs to be constantly improved. ISO 9004:2009 provides guidance that goes beyond the requirements given in ISO 9001 and includes consideration of the effectiveness and efficiency of the quality management system and therefore the potential for improvement across the organization.

ISO 9004:2009 is applicable to the processes of an organization and thus the quality management principles on which it is based can be extended to the entire organization. The focus of this standard is on achieving continual improvement as measured by the satisfaction of customers and other interested parties.

In the context of the global financial crisis, lean manufacturing is becoming increasingly important. After all, now the main task of each enterprise is not only to survive in such difficult conditions, but also to continue to develop. To do this, it is necessary to increase the efficiency of the enterprise in all areas of activity. First of all, this will happen by optimizing costs, increasing the productivity of available resources, as well as improving the quality of products.

Summing up, it should be noted that the analysis of documentation and documented procedures at the enterprise of OAO Nefteyuganskneftekhim showed the following positive aspects:

1. All documentation of the enterprise is developed in accordance with international standard 9001:2008;

2. Management, analysis, relevance of documented procedures is carried out in accordance with the requirements of STP 4.2.3-01 "QMS Documentation Management", STP 4.2.4-01 "Records Management", STP 8.3-01 "Nonconforming Products Management", STP 8.5. 2-01 "Procedure for taking corrective and preventive actions";

3. In addition to the requirements of the standard, additional procedures are included in the quality manual;

4. The activity of the enterprise complies with MS ISO 14001:2004, the health and safety management system complies with the requirements of OHSAS 18001:2007.

On the other hand, the study and evaluation of the effectiveness of the implementation of the QMS in the enterprise and the issues of implementation in general revealed the following problems:

1. The quality manual does not develop clause 4.2.3 (f) of the standard “Ensuring the identification of documents of external origin determined by the organization as necessary for it to plan and operate the quality management system;

2. The quality manual does not include a procedure for identifying, restoring and withdrawing records;

3. When analyzing the dynamics of capital-labor ratio, there is a downward trend in this indicator;

4. Due to a decrease in demand from consumers, there is a tendency to reduce the volume of production of the main types of products: EPDM, neonol, styrene, ethylene oxide, polyethylene.

To improve the documented procedures at the enterprise, it is necessary to carry out the following activities:

1. Introduction into STP 4.2.3-01 "QMS Documentation Management" a procedure for identifying documents of external origin, determined by the organization as necessary for it to plan and operate the quality management system;

2. Inclusion in STP 4.2.4-01 "Records Management" a documented procedure for the identification, restoration and removal of records;

3. Making the necessary decisions to increase the capital-labor ratio at the enterprise, in particular, the modernization of production and optimization of the number of workers;

4. entering new markets and searching for new partners, which can lead to an increase in the volume of production of the main types of products.

To improve the quality management system as a whole, as well as adopting the experience of advanced and foreign enterprises, the following activities are possible:

Transition to an integrated quality management system using MS ISO 9004:2009, which ensures sustainable and innovative development enterprises;

Transition to the "lean manufacturing" system, aimed at continuous improvement of the organization's activities and achievement of its long-term competitiveness.

According to the ISO 9000:2000 standard, the principle of continuous improvement of the organization as a whole (and therefore its QMS) is one of the 8 fundamental principles of quality management. When implementing this principle, one should be guided by the recommendations for improving the QMS given in the ISO 9004:2000 standard. The essence of these recommendations is that all systems and processes of the organization should be constantly measured, analyzed and improved. This should be done by process teams, all team members under the direction of the owners and with the overall coordination of the management of the organization. Continuous improvement results in a 10-20% annual business improvement for the entire organization.

If we talk about life cycle processes, then special attention should be paid to the stage of research and product development. This is due to the well-known principle of increasing by an order of magnitude the cost of quality with each stage of progress from design to production, delivery of products, and then to its operation, that is, if preventing or eliminating an error at the design stage costs 1 thousand rubles, then at the stage of machine production it will cost 10 thousand rubles, at the stage of installation and commissioning at the customer - 100 thousand rubles, during operation it will cost 1 million rubles, if at all it turns out to be possible.

Studies of the costs of quality assurance in domestic engineering lead to similar results. They are illustrated by the data presented in Table. 2.17.

Table 2.17. Influence of total costs by product life stages on quality assurance

The basic principles and methods of continuous quality improvement were formulated by leading American companies in their industries: AT&T, Avon, Corping Glass, General Motors, Hewlett‑Packard, IBM, Polaroid.

1. Achieving the interest of senior management.

2. Establishment of a leadership council for quality improvement.

3. Involvement of the entire management team.

4. Ensuring collective participation in quality improvement.

5. Ensuring individual participation in quality improvement.

6. Creation of groups for improving systems, regulating processes.

7. More complete involvement of suppliers in the struggle for quality.

8. Measures to ensure the quality of the functioning of the management system.

9. Short-term plans and long-term strategy for improving performance. 10. Creation of a system for recognizing the merits of performers.

These directions reflect the essence of the organizational and economic foundations of continuous quality improvement.

Starting around the 1980s, methods of radical organizational improvement began to develop and be used more and more. They are also called business process improvement techniques (BPIs). They are short-term in nature and are aimed at improving one or more business processes - mainly in the field of management, such as cost management, procurement, ordering, transportation of products or semi-finished products, warehousing of products, relations with suppliers and customers, product and process design, etc. .

The fact is that if production processes in the 1950s and 80s were developing vigorously and could already provide zero defects or several units of deviations per million products, then business management processes have not changed much since the beginning of the 20th century and an error of 20% was considered quite acceptable. As a result, BP management became a brake on the development of organizations and several methods were proposed for their radical (by 300-1500%) improvement in a short period of time (2-6 months).

This methodology combines approaches such as benchmarking (bench-marking), updating (reengineering) processes, targeted improvements, developing new processes, innovative processes, determining the costs associated with activities, and analyzing the big picture, in one logical path to introduce radical and rapid changes into a single business process. Poll production organizations Japan, Germany and the United States, SBP is recognized as the most important approach used around the world to improve organizations. Among the most effective methods, analysis of the types and consequences of FMEA failures(Japan), Pareto analysis (Germany), statistical process control (USA).

The most important difference between the SBP methodology and continuous improvement is that the latter focuses on eliminating and preventing errors, while the former focuses on doing things right right away.

BPS is the systematic use of cross-functional teams to analyze and improve the way an organization works by improving the efficiency, productivity, and adaptability of organizational processes.

Improving business processes will give your organization the effects shown in Table. 2.18.

Table 2.18. Business Process Improvement Effects

Here are typical examples of improvements achieved with SBP:

Output quality improved by 1000%;

Overhead costs are reduced by 30-50%;

Cycle time reduced by 40-60%;

Delivery time reduced from weeks to hours;

The number of ideas generated by employees has increased by 100% and their quality has improved by 50%;

Power increased by 40-60%;

Inventories were reduced by 50-70%.

Experience has shown that the use of SBP even for one process has a great impact on the entire organization and creates significant destruction in it, and for more than three processes it generates a tendency for the organization to go out of control. With this in mind, despite the high efficiency of the SBP for individual processes, continuous improvement can be more beneficial for the organization as a whole. It is promising to use both approaches simultaneously.

Suppose that in a year an organization that has about 500 internal BPs has improved 3 out of 500 processes by 1000%. At the same time, the organization’s activities as a whole have only improved by 6% (Fig. 2.27).

Rice. 2.27. Changes in indicators with continuous and radical improvement, as well as without improvement and when using both of its types

Compare these results with the continuous improvement methodology, which is applied to all 500 processes and results in a 15% improvement per year. It can be seen that the continuous improvement methodology outperforms the SBP methodology by 9% per year and gives a 10% advantage over competitors. This advantage is explained by the fact that all employees are working to improve all production and business processes.

If an organization does not improve, it does not remain in place in the market, but slides down at a rate of 5-10% per year compared to competitors, as they improve (see Figure 2.27).

When radical and continuous improvement are combined, the resulting improvement exceeds continuous improvement by 60% per year (see Figure 2.27). It is for this reason that an organization should use both types of improvement if it really wants to be the best it can be.

Given in Table. 2.19 the list shows the differences in the methods of approach of organizations to continuous and radical improvement.

The choice of improvement strategy is made by the management of the organization based on an analysis of the state of affairs in the organization. An engineering company can use the following list of questions for this.

1. Does the number of consumers of goods and services of your enterprise increase from year to year?

2. Are your losses from marriage and the cost of correcting defects less than 1% of the cost of goods sold?

Table 2.19. Continuous and radical improvement

3. Do you follow production schedules?

4. Do you stick to planned production costs?

5. Do you use only those materials, parts and components that meet the requirements of specifications?

6. Do you have less than 5% loss of work time due to absenteeism, absenteeism or other reasons?

7. Is the annual turnover work force less than 5%?

8. Are you able to attract the best shots to your enterprise?

9. Do you spend the right amount of money on training your personnel, taking into account the size of losses from personnel errors?

10. Do your employees perform their duties during 90% of the working time?

11. Do you correctly understand the requirements of your customers for your products or services?

12. Would you like to boost the morale of your employees?

13. Do you think that the employees of the enterprise can work better than they work?

14. Does your incoming inspection reject less than 1% of the parts and components that enter your enterprise?

15. Do controllers make up less than 5% of production workers in your enterprise?

16. Does it take overtime work of your non-manufacturing workers less than 5% of the time?

17. Do you think it is possible to reduce production costs and reduce the duration of the production cycle?

18. Can you boast of having no complaints from your customers if you were counting on good reviews?

19. Have your firm's productivity growth rates over the past 5-10 years been higher than inflation rates?

20. Have your share dividends grown at a higher rate than inflation over the last 5 years?

A positive answer (“yes”) should be scored as 1 point. Based on the results of evaluating the answers to all questions in the form of a sum of points, the following recommendations can be made.

18-20 - the company is doing well. The process of continuous improvement must be carried out as usual in order to keep up with competitors.

14-17 - the process of continuous improvement needs to be intensified.

10-13 - it is necessary to identify 1–2 production or BP that worsen the work of the enterprise to the greatest extent, and apply the SBP methodology to them along with continuous improvement of other processes. Then apply SBP for 1-2 other PPs or BPs. Repeat the cycle until the number of points reaches 18–20.

0-9 - with the help of SBP of key production or BP, bring the number of points to 10-13. Then apply the strategy recommended above.

The Radical Business Process Improvement (SBP) methodology can be divided into 5 sub-processes called phases.

Phase I. Organization of improvement work. The administrative improvement team learns the BPS methodology, selects critical processes and assigns their owners. The process owner forms a Process Improvement Team (PCT) that establishes process boundaries, measurable parameters for the entire process, identifies process improvement goals, and develops a project plan.

Phase II Process understanding. Unfortunately, most business processes are not documented, and if they are documented, they often do not follow this documentation. During this phase, the PCB analyzes the existing process (“as is”), checks compliance with current procedures, collects data on costs and cycle times, and aligns daily activities with procedures.

This phase contains 6 actions:

Construction of diagrams (block diagrams) of process flows;

Preparation of a simulation model;

Systematic review of the process;

Process cost and cycle time analysis;

Introduction of quick snap;

Alignment of process with procedures.

The goal of phase II is to study the process in detail and its components (cost, cycle time, processing time, error rate, etc.). A flow diagram and a simulation model of an existing process (a process "as is" model) will be useful for its improvement during phase III.

Phase III. Process rationalization. To understand the difference between process redesign, benchmarking, and new process development (process reengineering), let's focus on phase III, where all these 3 methodologies are applied.

The rationalization phase is the most important for improving business processes. It is here that the SBP methodology is being worked out, and the creative abilities of the PCB members are actually used.

The rationalization phase consists of 6 actions (Fig. 2.28):

Process redesign;

Development of a new process;

Benchmarking;

Analysis of improvements, costs and risks;

Choice of preferred processes;

Pre-implementation planning.

This phase uses 3 different approaches.

1. Process redesign (targeted improvements, process reengineering).

2. Development of a new process (innovation process).

3. Benchmarking.

Process redesign. This approach (Table 2.20) eliminates various wastes in the existing process while reducing cycle time and improving efficiency. Once the process flow diagram has been redesigned, automation and information technology are used to maximize the process's ability to improve efficiency, productivity, and adaptability. Process redesign is sometimes referred to as focused improvement because it focuses on the existing process. Redesign results in improvements ranging from 300-1000%.

Table 2.20. Process redesign

Development of a new process. A new process design methodology begins with the creation of an ideal process model. Then developed new process that implements this model. This takes into account the latest achievements in mechanization, automation, computerization and information technology, which are available, resulting in improvements of 700-2000%. The development of a new process is sometimes referred to as the process of innovation, since its success is largely based on the innovation and creativity of the PCB members, or process reengineering.

Benchmarking. This very popular tool allows you to compare an existing process with the best similar process in the same or different industries.

Not all processes go through redesign, development of new options and benchmarking. One, two or all three of the above methodologies are used, depending on the circumstances.

Process redesign is most commonly used because it usually lowers the risks and costs. Typical results of this approach are 200-1000% improvement for approximately 70% of business processes.

The development of a new process, providing the greatest degree of improvement, requires the most cost and time to implement, but involves a high degree risk. Often the development of a new process involves restructuring departments and is very disruptive to the organization. Most organizations can only effectively implement one change of this magnitude at a time.

Benchmarking provides a proven measurement methodology that can be used to evaluate and select a range of alternatives. Benchmarking is useful about 10% of the time.

Phase IV Implementation, measurement and control. In this phase, the team is engaged in the "installation" of the selected process, measurement and control systems. New measurement and control systems should provide feedback to employees so that they feel the results of the improvements already achieved and improve the process further.

This phase consists of the following 5 activities:

Final implementation planning;

Implementation of a new process;

Creation of measurement systems in the process;

Establishment of a feedback data system;

Determination of the cost of poor quality.

Phase V. Continuous improvement. Now that the process performance has changed drastically, the process needs to continue to improve, but usually at a much slower rate (10-20% per year). During this part of the cycle, the process owner will monitor the efficiency, performance and adaptability of the entire process. Departmental improvement teams (natural working groups), each in their area of ​​expertise, will continually work to improve their part of the process. This is the most acceptable approach.

Let us analyze the results of the SBP obtained in some organizations.

McDonnel Douglas reduced overhead costs by 20-40%; stocks have been reduced by 30–70%; the cost of materials has been reduced by 5-25%; 60-90% improved quality; administrative expenses were reduced by 20-40%.

At Federal‑Mogul, the development cycle time has been reduced from 20 weeks to 20 business days, with a 75% reduction in production time.

Morton International Castings has reduced inventory of finished products and raw materials by 10-20%; 10-15% improved cycle time.

Colgate Palmolive reduced the cost of managing orders and distribution by 25%. increased the number of sales due to improved customer service.

Reduced the number of warehouses in Grand Met from 24 to 8; the range of services to consumers has been increased by 30%; reduced cycle time for order/delivery management.

Literature

1.ISO 9001-2000. Quality management systems. Requirements.

2. Ogvozdin V. E. Quality control. Fundamentals of theory and practice. – M.: Business and Service, 2002.

3.ISO 9000-2000. Quality management systems. Fundamentals and vocabulary.

4. Meskon M. H., Albert M., Hedouri F. Fundamentals of management / Per. from English. – M.: Delo, 1992.

5. Total quality management: Textbook for universities / Gludkin O. P., Gorbunov N. M., Gurov A. I., Zorin Yu. V. / Ed. O. P. Gludkina. - M .: Radio and communication, 1999.

6. Koreshkov V. N., Gorbar A. V. Head of quality management. - Minsk: Bel-GISS, 2001.

7. Technology of technical control in mechanical engineering. Help Guide/ Under the total. ed. V. N. Chupyrin. - M.: Publishing house of standards, 1990.

8.ISO 9004-2001. Quality management systems. Recommendations for improving performance.

9. The procedure for implementing a quality management system in an organization // Methods of quality management. - 2001. - No. 10.

10. Wirsan V. Strengths and weaknesses of standards ISO series 9000 new version: implementation strategy // Standards and quality. - 2001. - No. 12. - P. 56–61.

11. Smirnov V. A., Bruver A. V., Amyaliev A. A. Experience in developing a quality system // Methods of quality management, 2002. - No. 8.

12. Sorokin V. N. Our discovery of America // Standards and quality. - 2002. - No. 3.

13. Lapidus V. A. Statistical methods, total quality management, certification and something else… // Standards and quality. - 1996. - No. 4–7.

14. KondoE. Company-wide quality management. - Nizhny Novgorod: SMC "Priority", 2002.

15. M. Porter. Competition: Per. from English. - M .: Williams Publishing House, 2000.

16. Mark D. A., McGowan K. Methodology of structural analysis and design / Per. from English. – M.: 1993.

17. Hammer M., ChampyD. Reengineering of the corporation: a manifesto for a revolution in business: Per. from English. - S. Pb.: St. Petersburg University Publishing House, 1997.

18. Gardner R. Ten Lessons on Process Improvement for Managers // Quality Management Methods. - 2003. - No. 7.

19. Sweetkin M. Process approach to the implementation of quality management systems in organizations // Standards and quality. - 2002. - No. 3.

20. Thomas A. Little. Ten requirements for an organization effective management process // Standards and quality. - 2003. - No. 4.

21. Eliferov V. G. International standard ISO 9001:2000 "in the palm of your hand" // Methods of quality management. - 2003. - No. 9.

22. Ivanova G. N., Polotsky Yu. I. Using the process approach in the quality management system // Methods of quality management. - 2001. - No. 9.

23. Taguti G., Fadke M. Optimal design as a quality technique // Methods of quality management. - 2003 - No. 9.

24. Adler Yu. P., Shper V. L. On the way to statistical process control // Methods of quality management. - 2003. - No. 3.

25. Lapidus V. A. Statistical process control system. Shewhart system // Reliability and quality control. - 1999. - No. 5–7.

26. Vladimirtsev A. V., Martsinkovsky O. A., Shekhanov Yu. F. Quality management system and process approach // Methods of quality management. - 2001. - No. 2.

27. BerzhK. The theory of vultures and its application. - M .: Foreign literature, 1962.

28. Kane M. M., Aleshkevich I. L. and others. Statistical analysis of interdependencies between various accuracy indicators of spur gears during gear milling and shaving in working conditions/ Sat. Art. "Mechanical Engineering and Instrumentation". - Mn .: "The highest school", 1974. - Issue. 6.

29. Adler Yu. P., Shchepetova S. E. The further into the forest, the more processes // Methods of quality management. - 2002. - No. 8.

30. Repin V.V. Experience in implementing a business process management system // Methods of quality management. - 2003. - No. 5.

31. Gardner R. Overcoming process paradoxes // Standards and quality. 2002. - No. 1.

32. Kremser W. Project management - the path to business process management? // Methods of quality management. 2003. - No. 12.

33. ISO 9004‑4:1993. Part 4. Guidelines for quality improvement.

34. Solomakho V. L., Tsitovich B. V., Temichev A. M., Smirnov V. G. Standardization and certification. - Mn.: "VUZ‑Unity". 2001.

35. Craig R.J. ISO 9000: Guidelines for obtaining a registration certificate. - M .: RIA "Standards and Quality", 2000.

36. Kachalov V. A. Inconsistencies in QMS certification: Some results of the first audits according to ISO 9001:2000 // Methods of quality management. - 2003. - No. 11.

37. Mikulchik A. A., Michasov V. A. Document management in the quality system of an enterprise // Methods of quality management. - 2002. - No. 4.

38. Mikulchik A. A., Michasov V. A., Vlasov S. E. Automation of document management in the quality system of an enterprise // Methods of quality management. - 2003. - No. 4.

39. Nikitin V. A. Based quality management ISO standards 9000:2000. - St. Petersburg: Peter, 2002.

40. Kondrikov V. A. Comprehending the philosophy of quality // Standards and quality. - 2003. - No. 11.

41. Afanasiev A. A. Management system plus… // Standards and quality. 2002. - No. 4.

42. Maksimov Yu. A., Papkov V. I. QMS as a means of increasing the competitiveness and efficiency of an enterprise // Methods of quality management. - 2003. - No. 11.

43. Polotsky Yu. A., Vinogradov A. V. Identification and description of the network of processes // Methods of quality management. - 2002. - No. 11.

44. Niv G. The space of Dr. Deming. Book. 1. - Tolyatti: City public fund "Development through quality", 1999.

45. Goncharov E. How to develop a quality management system in accordance with process approach// Standards and quality. - 2003. - No. 12.

46. Adler Yu. P., Shepetova S. E. Process under the microscope // Methods of quality management. - 2002. - No. 7.

47. Galeev V. I., Pichugin K. V. Kitchen of the process approach // Methods of quality management. 2003. - No. 4.

48. Zworykin N. M. Implementation of the process approach at an industrial enterprise // Methods of quality management. - 2004. - No. 1.

49. Maklakov S.V. BPwin and Erwin: CASE - information systems development tools. - M.: DIALOGUE - MEPhI, 2000.

50. Kutyrkin S. B., Volchkov S. A., Balakhonova I. V. Improving the quality of an enterprise with the help of information systems of the ERP class // Methods of quality management. - 2000. - No. 4.

52. "Seven instruments of quality" in the Japanese economy. - M .: Publishing house of standards, 1990.

53. Ivlev V., Popova T. Application of software in the quality management system // Standards and quality. - 2004. - No. 1.

54. Chaika I., Galeev V. Standards ISO 9000 series version 2000: how to master them in Russia // Standards and quality. - 2001. - No. 5–6.

55. Sweetkin M. Standards ISO 9000 series version 2000: new steps in the practice of quality management // Standards and quality. - 2000. - No. 12.

56. Sweetkin M. Practical aspects of the implementation of ISO 9000: 2000 standards // Standards and quality. - 2003. - No. 1.

57. Aleshin B. S., Aleksandrovskaya L. N., Kruglov V. I., Sholom A. M. Philosophical and social aspects quality. – M.: Logos, 2004.

58. Basovsky L. E., Protasiev V. B. Quality Management: Textbook. – M.: INFRA-M, 2003.

59. Vorontsova A. N., Polyanchikov Yu. N., Skhirtladze A. G., Korotkov I. A. A systematic approach to forecasting technology and production: Proc. allowance. – M.: Globus, 2006.

60. Revenko N. F., Skhirtladze A. G., Belosludtseva G. B. et al. Organization of production and management at machine-building enterprises: Sat. tasks. – M.: graduate School, 2007.

61. Vorontsova A. N., Polyanchikov Yu. N., Skhirtladze A. G., Boriskin V. P. Design and production of products: Proc. allowance. – Art. Oskol: TNT, 2007.

62. Organization, regulation and stimulation of labor at engineering enterprises: Textbook. - M .: Higher school, 2005.

63. Revenko N. F., Skhirtladze A. G., Aristova V. L. et al. Organization and regulation of labor in mechanical engineering: Proc. allowance. – M.: MGOU, 2004.