Prevention of quality problems: the experience of the Tractor Plants Concern. Quality audit A means of preventing deterioration of the quality system is to

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Exercise 1

Question 1. What is the term defined long-term quality management and organization of work to control the company's compliance with state standards of products?

1. quality management

2. total quality management

3. certification

4. standardization

5. metrology

Question 2. What is the term for the relationship between dependent and independent variables, expressed in the form of a table, text, graph?

1. property

2. principle

4. characteristic

5. need

Question 3. What term is used to denote the result of activities or processes of internal activities of enterprises?

3. products

5. system

Question 4. What does the aggregate mean? organizational structure, methodologies, processes and resources needed to implement total quality management?

1. quality system

2. quality level

3. relative quality

4. characteristic

5. process

Question 5. What place in the world did Russia occupy in terms of the quality of life of the population in 1994?

Task 2

Choose the correct answer for the question.

Question 1. At what stage is the product quality formed?

1. conclusion of a supply contract

2. workmanship

4. Quality control

5.Design

Question 2. From whose position was considered the quality of products in a command-administrative economy?

1. consumer

2. enterprise management

3. higher authority

4. ministries

5. Gosstandart of the Russian Federation

Question 3. What is the name of the science of how to measure and quantify the quality of products and services?

1. mechanics

3. qualimetry

4. marketing

5. electronics

Question 4. What contributes to improving the quality of products produced by domestic producers?

1. growth in imports of goods

2. decrease in competitiveness

3. increase in gold reserves

4. growth of export opportunities

5. efficient use of natural resources

Question 5. What are the products compared to in the process of checking the quality of manufactured products?

1. similar products of other enterprises

2. design data

3. enterprise standards

4. control sample

5. standard (standard)

Task 3.

Question 1. How many International Standards of the 9000 X series on quality systems were developed and approved in 1987 by the Technical Committee of the International Organization for Standardization?

3. four;

Question 2. How many stages of the product life cycle does the ISO standard provide?

Question 3. Decision-making in product quality management at the enterprise is based on control, accounting and:

1. analysis;

2. planning;

3. forecasting;

4. marketing;

5. designing .

Question 4. How many fundamental conditions are formulated in modern management quality?

4. twelve

Question 5. With the production of what type of product should start the development of production?

1. technological;

2. expensive;

3. less labor intensive;

4. in demand;

5. for which technical documentation has been developed.

Task 4.

Mark the correct answer on the answer sheet.

Question 1. On the basis of what document was carried out at the beginning of the century to obtain consumer information about the quality of the goods?

3. specifications;

4. drawing;

5. Manufacturer's Warranty.

Question 2. What is the name of a figure in international business, but similar in form to the former "Quality Mark"?

1. Mausoleum;

2. Acropolis;

3. Eiffel Tower;

4. Pentagon;

5. Elephant tusk.

Question 3. What is an example of counter (bottom-up) vertical product quality management:

1. system of defect-free labor;

2. scientific organization work to increase the motor resource of engines;

3. quality circles;

4. comprehensive quality management system;

5. defect-free product manufacturing.

Question 4. How many stages in the development of quality systems can be identified in the history of the XX century?

4. eight;

5. nine.

Question 5. On what cycles is the TQM system based?

1. Feigenbaum;

2. Proudhon;

3. Ishikawa;

4. Deming;

5. Bogolyubova.

Task 5.

Mark the correct answer on the answer sheet.

Question 1. Who is the coordinating federal executive body in such areas as standardization, certification, metrology?

1. State Committee for Science and Technology;

2. Ministry of Economy of the Russian Federation;

3. Ministry of Labor and social issues RF;

4. Gosstroy of the Russian Federation;

5. Gosstandart of the Russian Federation.

Question 2. What management methods are the scientific basis of modern technical control?

1. Delphi;

2. balance:

3. mathematical and statistical;

4. complex analysis;

5. forecasting.

Question 3. What approach to process optimization does statistical process control provide?

1. random

2. individual;

3. complex;

4. systematic:

5. permanent.

Question 4. How many stages have historically arisen in the evaluation of product quality?

2. three;

3. four:

Question 5. What is the first step in assessing product quality?

1. definition of the nomenclature of certified products;

2. acquisition of equipment necessary for quality control;

3. choice of nomenclature of quality indicators;

4. training of personnel of the technical control department;

5. drawing up a plan of inspections.

Task 6.

Mark the correct answer on the answer sheet.

Question 1. What system of organization of defect-free manufacturing of products (BIP) became widespread in our country in the 1950s?

1. Leningrad;

2. Volgograd;

3. Saratov;

4. Minsk;

5. Kaliningrad.

Question 2. What method of product quality control at enterprises was the main one when using the Saratov BIP system?

1. solid;

2. selective;

3. lack of control;

4. self-control;

5. brigade.

Question 3. What was the main criterion for the application of an integrated product quality management system:

1. compliance of product quality with the highest achievements of science and technology;

2. compliance of the quality of the result of labor with the established requirements;

3. compliance of the achieved level of motor resource with the planned value;

4. Conformity quality first industrial products established requirements;

5. Compliance with international quality standards.

Question 4. The purpose of which product quality management system was to ensure the release of products of excellent quality, high reliability and durability?

1. CANARSPI;

Question 5. What product quality management system covered many types of work at the stage of research and design and at the stage of operation?

1. CANARSPI;

Task 7.

Mark the correct answer on the answer sheet.

Question 1. By what percentage was the increase guarantee period engine operation as a result of using the NORM quality management system?

Question 2. In what year were the Basic Principles developed and approved by Gosstandart unified system government controlled product quality?

Question 3. Which department in the enterprise coordinates the planning of activities in the field of quality?

1. planning department;

2. technical department;

3. technological department;

4. design department;

5. quality assurance department.

Question 4. Who in the enterprise is responsible for the practical use of the product quality management system?

1. chief engineer;

2. director;

3. Deputy quality director;

4. head of the technical control department;

5. head of the technical department.

Question 5. In what sense is the newly introduced provision that all the work performed by the organization is considered as a set of interrelated processes is fundamental to the ISO 9000-1y94 system?

1. methodological

2. technical

3. ideological

4. technological

5. economic.

Task 8.

Mark the correct answer on the answer sheet.

Question 1. The credo of prosperous firms all over the world is to win a buyer through:

1. low prices;

2. quality;

3. design;

4. low labor intensity;

5. profitability of products.

Question 2. How many companies in the world have certified quality systems?

Question 3. To improve what results of the activities of enterprises is aimed at improving the quality of products?

1. technical

2. technological

3. economic

5. design

Question 4. What percentage of contracts for the supply of products in Russia provide confirmation of the existence of a quality assurance system that complies with the ISO 9000 series?

Question 5. How many enterprises in Russia have passed the certification of quality systems?

Task 9.

Mark the correct answer on the answer sheet.

Question 1. In which city was the first Global Quality Management Forum held in 1994?

1. London;

2. Paris;

3. Moscow;

4. Milan;

5. Khartoum.

Question 2. What are the names of the contracts concluded by the Russian Federation at the government level?

1. state;

2. international;

3. ministerial;

4. interregional;

5. industry.

Question 3. What influences, first of all, the process of implementing total quality management?

1. public opinion;

2. the state of the economy;

3. market relations;

4. country legislation;

5. the desire of business leaders.

Question 4. What methods are used to analyze and control processes at all stages of the product life cycle?

1. Statistical;

2. analytical;

brain teaser;

3. planning;

4. engineering and mathematics.

Question 5. What methods are methods for assessing product quality?

1. stimulation;

2. control;

3. motivation;

4. self-control;

5. statistical.

Task 10.

Mark the correct answer on the answer sheet.

Question 1. In what year did “quality circles” form at enterprises in Japan?

Question 2. What system of organization of relationships contributes to the improvement of the enterprise through competent management and conscious behavior of each employee of the company?

1. controlling;

2. democratic;

3. corporate culture;

4. scientific;

5. technological.

Question H. What is necessary condition transition in the enterprise to self-control of products?

1. retraining of personnel;

2. change in the technological regime;

3. improving the quality of technical documentation;

4. stimulation of the management of the enterprise;

5. development of a system to encourage workers.

Question 4. What methods of product quality management are recognized as an important condition for improving the profitability of products?

1. self-control;

2. statistical;

3. economic and mathematical;

4. social;

5. technical.

Task 11.

Mark the correct answer on the answer sheet.

Question 1. What data is used to build a histogram?

1. accounting;

2. analytical;

3. generalized;

4. measurable;

5. cumulative.

Question 2. What method of assessing product quality is used when it is required to establish how many fluctuations in the process are caused by random changes?

1. control card;

2. time series;

3. Pareto chart;

4. histogram;

5. scatterplot.

Question 3. What kind of analysis do control charts allow?

1. economic efficiency;

2. technical feasibility;

3. demand for manufactured products;

4. process capabilities;

5. reasons for marriage.

Question 4. How many types of control charts are used to characterize the qualitative characteristics of products?

3. four;

Question 5. What method of assessing product quality is used when it is required to determine what happens to one of the variables if another variable changes?

1. control card;

2. time series;

3. Pareto chart;

4. histogram;

5. scatterplot.

Task 12.

Mark the correct answer on the answer sheet.

Question 1. What is the term for checking the compliance of the object of control with the established technical requirements?

1. organization of control; technical control; control for compliance with GOST;

2. assessment of product quality;

3. documentary control.

Question 2. What are the efforts of the world's leading firms in the field of product quality control in the first place aimed at?

1. improvement of control methods;

2. development of an effective system of rewarding employees for reducing marriage;

3. prevention of marriage;

4. changes in the methods of punishment for an admitted marriage;

5. improvement of the technological regime.

Question 3. The purpose of which control method is to exclude random changes in product quality?

1. epistemological;

2. analytical;

3. statistical;

4. mathematical analysis;

5. social.

Question 4. In what type of plans for statistical control of a batch of products, the number of control steps is predetermined?

1. single stage;

2. two-stage;

3. multistage;

4. sequential;

5. discrete.

Question 5. What is a probabilistic indicator of the statistical control plan?

1. operational characteristics;

2. the level of product quality;

3. volume of production;

4. coefficient of utilization of production capacities;

5. labor productivity.

Task 13.

Mark the correct answer on the answer sheet.

Question 1. What is the operational characteristic for sampling plans?

1. broken line;

2. straight line;

3. column;

4. smooth curve;

5. broken line.

Question 2. What control procedure continues until a defective copy appears in the sample?

1. solid;

2. discrete;

3. technologically necessary;

4. experimental-statistical;

5. relaxed mode.

Question 3. What are the names of the control charts that are used in making decisions about the product quality control regime?

1. registration;

2. cumulative;

3. double-cards;

4. simple,

5. complex.

Question 4. Which product quality control document starts turning opinions and assumptions into facts?

1. histogram;

2. scatter diagram;

3. control card;

4. control sheet;

5. Pareto chart.

Question 5. What quality control method is used when it is required to predict the relative importance of all problems in order to identify a starting point for solving problems?

1. histogram;

2. scatter diagram;

3. control card;

4. control sheet;

5. Pareto chart.

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Choose one answer:
persistence
reliability
maintainability
durability
transportability

Choose one answer:

marriage scores










4. Provide
Choose one or more answers:






Choose one answer:
leadership role
policy and strategy
business results
the role of company owners

Choose one answer:



document analysis


Choose one answer:
creative
research
special
general

Choose one or more answers:
phased innovations
bankruptcy of an organization
breakthrough projects
reorganization of the structure


Choose one answer:
quality planning

maintaining quality
quality assurance
quality improvement

Choose one or more answers:






Choose one answer:






Choose one answer:






Choose one or more answers:

product operation

product development stages


Choose one or more answers:



process management
self-sufficiency

Choose one answer:



enterprise reorganization


Choose one answer:
related
temporary
basic
permanent
introduced

Choose one answer:





18. Advantages of RMEA:
Choose one or more answers:






Choose one or more answers:


total quality control



Choose one or more answers:
organizational
market
universal
introduced
basic

Choose one or more answers:
industry standards
quality policy
laws of the Russian Federation
enterprise standards
specifications

Choose one answer:





23. The Deming cycle includes:
Choose one answer:


evaluate - decide - do



Choose one or more answers:

focus group work

cost calculation
input control

Choose one answer:
forecasting



consumer survey

Choose one answer:
certification
control
internal audit
inspections
self-esteem

Choose one answer:
regularity
courtesy
uniformity
independence
documentation

Choose one answer:






Choose one or more answers:
project documentation
production costs


terms of reference

Choose one answer:

1. The property of a product to remain operational for some time or operating time is:
Choose one answer:
persistence
reliability
maintainability
durability
transportability
2. Analysis of the cost of conformity and discrepancy of the quality of processes is a method:
Choose one answer:
determination of losses due to poor quality
marriage scores
process costing
quality costing
determination of losses due to high quality
3. Main contribution Japanese management qualities:
Choose one or more answers:
widespread use of standardization
reduction of marketing research costs
increase in quality costs
state support for quality projects
stimulate demand for the company's products
4. Provide The definition of product quality starts with:
Choose one or more answers:
organizational and technical preparation of production
representativeness of information about the quality of a competitor's product
selection of quality suppliers
accuracy assessment of metrological equipment
objectivity of consumer perception
5. The model of the European Quality Award does not include such an evaluation criterion as:
Choose one answer:
leadership role
policy and strategy
business results
the role of company owners
6. The main purpose of the internal audit:
Choose one answer:
proof of inconsistencies
verification of employees' knowledge of documents
verification of the adequacy of documents to international standards
document analysis
monitoring the work of the department
7. Causes that arise as a result of accidental impact on the process:
Choose one answer:
creative
research
special
general
8. Improving the quality of processes is implemented through:
Choose one or more answers:
phased innovations
bankruptcy of an organization
breakthrough projects
reorganization of the structure
processing business processes
9. Market research is implemented as part of the quality function:
Choose one answer:
quality planning
consumer quality design
maintaining quality
quality assurance
quality improvement
10. Metrological support allows:
Choose one or more answers:
control all stages of production
guarantee the unity and accuracy of measurement
control at the lowest cost
reproduce measurement results
influence consumer behavior
11. The function of maintaining quality involves:
Choose one answer:
development of quality improvement methods
continuous compliance with established and changing requirements
development of design quality requirements
development of consumer requirements
assessment of quality compliance with requirements
12. The main factors affecting the process:
Choose one answer:
external and internal environment of the enterprise
competitors, suppliers, consumers
people, machines, material, method, environment
finance, people, equipment, executives
goals, tasks, structure, technology, people
13. The main measures for maintaining quality are:
Choose one or more answers:
statistical methods of process control
product operation
research and pre-production
product development stages
internal audit and self-assessment
14. The key factors of total quality management are:
Choose one or more answers:
strategic planning quality
continuous improvement of the quality of work
maximization of current profit
process management
self-sufficiency
15. Quality is a set of product properties necessary for:
Choose one answer:
customer satisfaction
ensuring high staff motivation
attracting the interest of state bodies
enterprise reorganization
psychological impact on the leader
16. Have a seasonal impact on the consumer values:
Choose one answer:
related
temporary
basic
permanent
introduced
17. The statement "Quality management is the implementation of responsibility" means:
Choose one answer:
use of methods authoritarian control
refusal of additional incentives for employees
setting production standards higher than those of competitors
development of an additional document management system
increasing the ability of all employees to meet quality requirements
18. Advantages of RMEA:
Choose one or more answers:
reduction of defects at the manufacturer
reduction of defects at the consumer
increase in the design phase
complication of the terms of reference
ranking of defects according to the degree of significance
19. List the concepts of quality management:
Choose one or more answers:
classical school of management
statistical control quality
total quality control
doctrine of "human relations"
total quality management
20. A comprehensive study of consumer quality includes the study of values:
Choose one or more answers:
organizational
market
universal
introduced
basic
21. External quality documentation includes:
Choose one or more answers:
industry standards
quality policy
laws of the Russian Federation
enterprise standards
specifications
22. The decrease in the volume of input control is justified by:
Choose one answer:
customer satisfaction
using new production technologies
product quality improvement
continuous control errors
high cost of 100% control
23. The Deming cycle includes:
Choose one answer:
plan - execute - check - correct
motivate - plan - control
evaluate - decide - do
do - think - fill - decide
plan - organize - check - motivate
24. The formation of the design quality of the product begins with:
Choose one or more answers:
drafting project documentation
focus group work
development of terms of reference
cost calculation
input control
25. Consumer quality planning ends:
Choose one answer:
forecasting
assessment of opportunities and threats
analysis of strengths and weaknesses
structuring consumer requirements
consumer survey
26. Prevention of deterioration in quality is the goal:
Choose one answer:
certification
control
internal audit
inspections
self-esteem
27. The principle of conducting an audit according to a single procedure officially established by the management of the enterprise expresses:
Choose one answer:
regularity
courtesy
uniformity
independence
documentation
28. The main functions of quality management are:
Choose one answer:
production organization function, market research function, planning function
planning, improvement, provision
analytical function, control function, promotion function, audit
planning, designing, providing, controlling, maintaining and improving
production function, commercial function, competitiveness management
29. The formation of design quality is carried out on the basis of:
Choose one or more answers:
project documentation
production costs
meeting the requirements of buyers
production policy changes
terms of reference
30. Kaizen cycles include a step-by-step sequence of cycles:
Choose one answer:
punishment - suggestion - motivation - training
motivation - offer - reward
offer - support - reward - motivation to participate
reward - motivation - offers
training - reward - support - motivation

1. The property of a product to remain operational for some time or operating time is:
Choose one answer:
persistence
reliability
maintainability
durability
transportability
2. Analysis of the cost of conformity and discrepancy of the quality of processes is a method:
Choose one answer:
determination of losses due to poor quality
marriage scores
process costing
quality costing
determination of losses due to high quality
3. The main contribution of Japanese quality management:
Choose one or more answers:
widespread use of standardization
reduction of marketing research costs
increase in quality costs
state support for quality projects
stimulate demand for the company's products
4. Provide The definition of product quality starts with:
Choose one or more answers:
organizational and technical preparation of production
representativeness of information about the quality of a competitor's product
selection of quality suppliers
accuracy assessment of metrological equipment
objectivity of consumer perception
5. The model of the European Quality Award does not include such an evaluation criterion as:
Choose one answer:
leadership role
policy and strategy
business results
the role of company owners
6. The main purpose of the internal audit:
Choose one answer:
proof of inconsistencies
verification of employees' knowledge of documents
verification of the adequacy of documents to international standards
document analysis
monitoring the work of the department
7. Causes that arise as a result of accidental impact on the process:
Choose one answer:
creative
research
special
general
8. Improving the quality of processes is implemented through:
Choose one or more answers:
phased innovations
bankruptcy of an organization
breakthrough projects
reorganization of the structure
processing business processes
9. Market research is implemented as part of the quality function:
Choose one answer:
quality planning
consumer quality design
maintaining quality
quality assurance
quality improvement
10. Metrological support allows:
Choose one or more answers:
control all stages of production
guarantee the unity and accuracy of measurement
control at the lowest cost
reproduce measurement results
influence consumer behavior
11. The function of maintaining quality involves:
Choose one answer:
development of quality improvement methods
continuous compliance with established and changing requirements
development of design quality requirements
development of consumer requirements
assessment of quality compliance with requirements
12. The main factors affecting the process:
Choose one answer:
external and internal environment of the enterprise
competitors, suppliers, consumers
people, machines, material, method, environment
finance, people, equipment, executives
goals, tasks, structure, technology, people
13. The main measures for maintaining quality are:
Choose one or more answers:
statistical methods of process control
product operation
research and pre-production
product development stages
internal audit and self-assessment
14. The key factors of total quality management are:
Choose one or more answers:
strategic quality planning
continuous improvement of the quality of work
maximization of current profit
process management
self-sufficiency
15. Quality is a set of product properties necessary for:
Choose one answer:
customer satisfaction
ensuring high staff motivation
attracting the interest of state bodies
enterprise reorganization
psychological impact on the leader
16. Have a seasonal impact on the consumer values:
Choose one answer:
related
temporary
basic
permanent
introduced
17. The statement "Quality management is the implementation of responsibility" means:
Choose one answer:
use of methods of authoritarian management
refusal of additional incentives for employees
setting production standards higher than those of competitors
development of an additional document management system
increasing the ability of all employees to meet quality requirements
18. Advantages of RMEA:
Choose one or more answers:
reduction of defects at the manufacturer
reduction of defects at the consumer
increase in the design phase
complication of the terms of reference
ranking of defects according to the degree of significance
19. List the concepts of quality management:
Choose one or more answers:
classical school of management
statistical quality control
total quality control
doctrine of "human relations"
total quality management
20. A comprehensive study of consumer quality includes the study of values:
Choose one or more answers:
organizational
market
universal
introduced
basic
21. External quality documentation includes:
Choose one or more answers:
industry standards
quality policy
laws of the Russian Federation
enterprise standards
specifications
22. The decrease in the volume of input control is justified by:
Choose one answer:
customer satisfaction
using new production technologies
product quality improvement
continuous control errors
high cost of 100% control
23. The Deming cycle includes:
Choose one answer:
plan - execute - check - correct
motivate - plan - control
evaluate - decide - do
do - think - fill - decide
plan - organize - check - motivate
24. The formation of the design quality of the product begins with:
Choose one or more answers:
drafting project documentation
focus group work
development of terms of reference
cost calculation
input control
25. Consumer quality planning ends:
Choose one answer:
forecasting
assessment of opportunities and threats
analysis of strengths and weaknesses
structuring consumer requirements
consumer survey
26. Prevention of deterioration in quality is the goal:
Choose one answer:
certification
control
internal audit
inspections
self-esteem
27. The principle of conducting an audit according to a single procedure officially established by the management of the enterprise expresses:
Choose one answer:
regularity
courtesy
uniformity
independence
documentation
28. The main functions of quality management are:
Choose one answer:
production organization function, market research function, planning function
planning, improvement, provision
analytical function, control function, promotion function, audit
planning, designing, providing, controlling, maintaining and improving
production function, commercial function, competitiveness management
29. The formation of design quality is carried out on the basis of:
Choose one or more answers:
project documentation
production costs
meeting the requirements of buyers
production policy changes
terms of reference
30. Kaizen cycles include a step-by-step sequence of cycles:
Choose one answer:
punishment - suggestion - motivation - training
motivation - offer - reward
offer - support - reward - motivation to participate
reward - motivation - offers
training - reward - support - motivation

1.The meaning of standardization and certification

Quality system - a set of organizational structure, distribution of responsibilities, processes, procedures and resources that provides overall quality management. This definition is given in the international standard ISO 8402.

To conclude a contract for the supply of products, a foreign client puts forward a requirement that the manufacturer has a quality system and a quality system, that there is a certificate for a quality system issued by an authoritative certification body.

Quality management is largely based on standardization. Standardization is a normative way of managing. Its impact on the object is carried out by establishing norms and rules, formalized in the form of regulatory documents that have legal force.

A standard is a normative and technical document that establishes the basic requirements for product quality.

An important role in quality management belongs to specifications.

Specifications is a regulatory and technical document that establishes additional requirements for state standards, and in their absence, independent requirements for product quality indicators, as well as equated to this document. technical description, recipe, reference sample

The standards determine the procedure and methods for planning the improvement of product quality at all stages of the life cycle, establish requirements for the means and methods of quality control and assessment.

Product quality management is carried out on the basis of state, international, industry standards and enterprise standards.

International organizations for standardization and product quality

The excess of supply over demand, competitive fight for the buyer led to the need to develop objective indicators to assess the company's ability to produce products with the required quality characteristics. At the same time, the quality of manufactured and supplied products must be stable and sustainable throughout the duration of the contract. The guarantor of stability is the presence of a quality system in the manufacturer that meets internationally recognized standards.

The International Organization for Standardization (ISO) was established in 1946 by the UNO at a meeting of the Committee for the Coordination of UN Standards to promote standardization on a global scale to facilitate international trade and mutual assistance; to expand cooperation in the field of intellectual, scientific, technical, economic activity.

The main activity of ISO is the development of International Standards. ISO standards are voluntary for use. However, their use in national standardization is associated with the expansion of exports, the sales market, and maintaining the competitiveness of manufactured products.

International Electrotechnical Commission (IEC).

Created in 1906 in London. After its creation in 1946, ISO joined it on an autonomous basis, retaining independence in financial and organizational matters. Engaged in standardization in the field of electrical engineering, electronics, radio communications, instrument making. ISO - in all other industries.

The objectives of the IEC are to promote international cooperation in solving the issues of standardization in the field of electrical engineering, radio electronics. The main task is to develop international standards in the relevant field.

Modern methods of quality management are increasingly used in Russian enterprises. However, there is still a backlog from foreign firms.

For example, product certification (independent confirmation of product compliance with established requirements) in countries with market economies was introduced in the early 80s. In Russia, the law "On Certification of Products and Services" appeared in 1992.

The first editions of the ISO 9000 series of international standards have been released. By the beginning of the 1990s, certification of quality systems abroad had become widespread. In Russia, the first certificate for the quality system was issued in 1994.

Since the mid-1990s, experts and practitioners abroad have been linking modern methods quality management with the TQM methodology - general (all-encompassing, total) quality management.

Certification of the quality system consists in confirming its compliance with certain requirements that the manufacturer has established/accepted

(independently or under the influence of external circumstances, for example, at the request of the customer).

Quality requirements are defined by the International Organization for Standardization (ISO or ISO). International Standard Organization - ISO. Requirements for quality systems are contained in the ISO 9000 series of standards:

ISO 9000 "General quality management and quality assurance standards - Guidelines for selection and use."

ISO 9001 "Quality system. Model for quality assurance in design and (or) development, production, installation and maintenance."

ISO 9002 "Quality system. Model for quality assurance in production and installation."

ISO 9003 "Quality system.. Model for quality assurance in final inspection and testing."

ISO 9004 "General quality management and elements of a quality system - Guidelines".

The basis of the State Standardization System Russian Federation(GSS) are five standards:

GOST R 1.0-92 " State system standardization of the Russian Federation. Basic provisions.

GOST R 1.2-92 "State standardization system of the Russian Federation. Procedure for the development of state standards."

GOST R 1.3-92 "State system of the Russian Federation. Procedure for coordination, approval and registration of technical specifications".

GOST R 1.4-92 "State system of the Russian Federation. Enterprise standards. General provisions."

GOST R 5 "State system of the Russian Federation. General requirements to the construction, presentation, design and content of standards.

There are three state quality standards in Russia:

GOST 40.9001-88 "Quality system. Model for quality assurance in design and (or) development, production, installation and maintenance"

GOST 40.9002-88 "Quality system. Model for quality assurance in production and installation."

GOST 40.9003-88 "Quality system. Model for quality assurance during final inspection and testing".

AT State standards Russian Federation includes the following provisions:

Requirements for the quality of products, works and services that ensure safety for life, health and property, protection environment, mandatory requirements for safety and industrial sanitation.

Requirements for compatibility and interchangeability of products.

Methods for controlling the requirements for the quality of products, works and services that ensure their safety for life, health and property, environmental protection, compatibility and interchangeability of products.

Basic consumer and operational properties of products, requirements for packaging, labeling, transportation and storage, disposal.

Provisions ensuring technical unity in the development, production, operation of products and provision of services, rules for ensuring product quality, safety and rational use all types of resources, terms, definitions and other general technical rules and regulations.

Conditions for preparing quality systems for certification:

Existence of well-established procedures.

Few returns/rejections.

Availability of testing laboratories.

High performance.

Availability of quality managers in the enterprises.

Application of statistical methods of process control.

Have documented procedures

Availability of institutionalized quality systems

Availability of a quality department

Organization of product control

Accurate definition of responsibility.

Organization of defect detection.

A certified quality management system is a guarantee of high stability and sustainability of the quality of products manufactured by the supplier.

Having a quality system certificate is a prerequisite for maintaining competitive advantage on the market.

1. No problems with production management.

2. Few claims from customers.

Options for assessing the supplier's quality management system by the customer:

The customer is satisfied with the statement that the supplier has a quality system.

The client asks to provide documents in support of such an assertion.

The customer wants to test and evaluate the supplier's quality system itself.

The client requires certification of the quality system by a body he trusts.

2. Quality system

The quality system is created and implemented as a means of ensuring the implementation of a certain policy and the achievement of the goal.

The company's policy in the field of quality is formed by the top management of the enterprise.

The quality system includes: quality assurance; quality control; quality improvement. It is created by the management of the enterprise as a means of implementing the quality policy.

The quality system includes a customer (consumer) and a supplier (manufacturer).

The quality system that ensures the company's policy and the achievement of the goal in the field of quality includes:

Marketing, search and market research.

Design and/or development technical requirements, product development.

Logistics.

Preparation and development of technical processes.

Production.

Control, testing and surveys.

Packing and storage.

Implementation and distribution

Installation and operation.

Technical assistance in maintenance.

Disposal after use.

The primary is the formation and documentation of the quality policy by the management of the company (enterprise).

In policy making, there may be following directions:

improvement of the economic situation of the enterprise by improving the quality;

expanding or conquering new markets;

achieving a technical level of products that exceeds the level of leading enterprises and firms;

defect reduction, etc.

The quality policy should be set out in a special document, drawn up in the form of a program.

The overall quality management system may have subsystems for certain types of products or activities of the company.

Quality assurance activities include:

planning and design;

design of technological processes and preparation of production;

manufacturing;

quality checking;

prevention of quality deterioration;

after-sales service;

obtaining information from the consumer;

checking the quality assurance system.

Example. The Aggregate Plant carried out work on the introduction of a product quality management system in connection with increasing competition in the sales market. The work proceeded according to the following scheme.

At the end of May, the General Director signed the "Guidelines for the quality of the aggregate plant". The document contains the main provisions for managing, ensuring and improving the quality of the plant's products, relating to all production departments, marketing, design and sales services.

A quality service has been created to coordinate all departments of the enterprise in the field of quality. Quality service develops guidelines by quality. Functionally and administratively, this service is subordinate only to to CEO.

The quality service is built in accordance with ISO 9001 standards.

The functional subordination of the plant services to the quality service is shown in fig. 6.1.

Rice. 1. Functional subordination of the plant services to the quality service

Thus, the functional subordination of the quality service includes: the marketing service, the development directorate, the production directorate, the economics and finance directorate, the personnel directorate, and the sales department.

The management of the enterprise not only controls the compliance of quality with international standards, but strives for continuous improvement of quality.

Specialized Services study the needs of consumers and their requirements for product quality.

Non-compliance of product quality with certain standards is revealed directly in the production process. For this, quality control is carried out throughout the entire technological chain:

input control of materials and components is provided by the relevant laboratories;

in the production of the plant, methods of active control are combined, built into technological equipment, as well as selective or complete control of operations and final control of finished products;

laboratories are equipped with special stands for periodic testing of products.

At the same time, the managers of the enterprises give priority to the prevention of quality deviations from the standards, rather than to detection and elimination.

All staff are involved in quality work. For this, measures have been developed to increase the motivation of employees, including flexible system incentives and penalties, advanced training.

Strict requirements have been established for management personnel, involving disciplinary and material measures for omissions in quality work, for unwillingness or inability to fulfill their duties.

The quality manual clearly describes the functions of each of the divisions of the plant and the duties of the heads of divisions, provides for specific responsibility for failure to comply with instructions.

A quality control system has been developed for the sale of products and the purchase of materials and components. For this, a contract is drawn up.

When selling products of the company, the quality service, legal bureau, financial and economic department carefully analyze the needs of the company and the wishes of the client.

3. Structuring the quality function

Each product should reflect the main functional and stimulating characteristics of quality. In this case, we are talking about the quality, which is determined by the consumer. It must be assumed that the buyer is unlikely to talk about many indicators of quality. He is interested in no more than two or three. Therefore, there is a problem of engineering embodiment of quality in the product.

To solve this problem, the Quality Function Structuring (QFK) method is applied.

SFC was developed in Japan in the late 60s. One of the first to use it was MITSUBISHI at a construction shipyard in Kobe. Subsequently, this method became widespread in the Ford Corporation.

The Ford Corporation defines the structuring of the quality function as follows:

"A planning tool for translating the quality characteristics that the customer requires (i.e., his wants, needs, expectations) into suitable product features.

The SFC model was developed by Dr. F Yaukuhara. The SFC process consists of four phases:

Product development planning.

Project structuring.

Planning technological process.

Production planning.

Phase 1: Product Development Planning

Buyer requirements are established, understood and translated into engineering design language in terms called Proxy Quality Measures. The most important ones are used for the next phase.

Phase 2 Structuring the project

Various concepts for developing a product that would satisfy the structuring requirements are considered, and the best one is selected. The project is then detailed, with particular attention to the essential characteristics of the product, which are calculated from the customer requirements structured in phase 1. The product development details are then structured in phase 3.

Phase 3. Process planning

The technological process of product development is considered. After selecting the most suitable process concepts capable of producing products given those characteristics that are already structured, the process is detailed in terms of essential steps and parameters. These characteristics are then structured in the next phase.

Phase 4. Production planning.

In this final phase, process control methods are considered. These methods must ensure that the products are produced in accordance with their essential characteristics identified in phase 2 and, therefore, satisfy the requirements of the buyer.

Therefore, throughout the 4-phase FCS process for product design, process development, and process engineering, a product is created that satisfies the customer's requirements.

SFC requires knowledge and experience from various areas and can be carried out by a team of specialists from different specialties.

4. Ongoing quality management

current management quality is related to the control of technological processes. The control parameters of the technological process are determined. Going outside the acceptable range of control parameters can lead to the release of defective products. Deviations of parameters occur under the influence of random factors. Statistical methods are used to control the quality of technological processes. The most common:

Pareto chart. It is used to assess the frequency of occurrence of defects (deviations in the dimensions of parts, low-quality raw materials, violation of the technological process, etc.).

The experience of studying the frequency of marriage shows that a small number of types of marriage makes up a large proportion of the total.

The total frequency of occurrence of defects in the "other" category should not exceed 10%, i.e., other types of defects should be included, the total share of which does not exceed 10%.

Ishikawa's scheme is a "fish skeleton".

Reflects the logical structure of relations between the elements, stages, works that make up the process under study. The scheme is based on the principle of four components that affect product quality: material, machines, raw materials, people. When constructing it, the factors are arranged in order of importance (the more significant factor is built closer to the goal). In this case, each factor goes through its own pre-processing cycle and can be divided into smaller, more detailed schemes. (see diagram).

The operations that make up the processing are shown by arrows. Each arrow is associated with estimates of certain indicators. For example, the product is heated, there is a need to control the temperature regime. "The fish skeleton is a tool for logical problem solving.

The scheme can be used in the analysis of the quality of products as a whole, as well as individual stages of its manufacture.

Checklists containing information about technological processes.

Histograms, control charts, etc. are used.

Control charts are one of the main tools in the vast arsenal of statistical quality control methods.

One of the main tools in the vast arsenal of statistical quality control methods are control charts. It is generally accepted that the idea of ​​the control chart belongs to the famous American statistician Walter L. Shewhart. It was stated in 1924 and described in detail in 1931. Initially, they were used to record the results of measurements of the required properties of products. The parameter going beyond the tolerance field indicated the need to stop production and adjust the process in accordance with the knowledge of the specialist managing production.

This gave information about when someone, on what equipment, received marriage in the past.

However, in this case, the decision to adjust was made when the marriage had already been obtained. Therefore, it was important to find a procedure that would accumulate information not only for a retrospective study, but also for use in decision making. This proposal was published by the American statistician I. Page in 1954. Maps that are used in decision making are called cumulative.

The control chart (Figure 3.5) consists of a center line, two control limits (above and below the center line), and characteristic (quality score) values ​​plotted on the map to represent the state of the process.

Rice. 5. Control card

In certain periods of time, n manufactured products are selected (all in a row; selectively; periodically from a continuous flow, etc.) and the controlled parameter is measured.

The measurement results are applied to the control chart, and depending on this value, a decision is made to correct the process or to continue the process without adjustments.

A signal about a possible adjustment of the technological process can be:

point going beyond the control limits (point 6); (the process is out of control);

the location of a group of successive points near one control boundary, but not going beyond it (11, 12, 13, 14), which indicates a violation of the equipment setting level;

strong scattering of points (15, 16, 17, 18, 19, 20) on the control map relative to the midline, which indicates a decrease in the accuracy of the technological process.

If there is a violation signal production process the cause of the violation must be identified and eliminated.

Thus, control charts are used to identify a specific cause, not a random one.

A definite cause is to be understood as the existence of factors that allow study. Of course, such factors should be avoided.

Variation due to random causes is necessary, it inevitably occurs in any process, even if the technological operation is carried out using standard methods and raw materials. The exclusion of random causes of variation is technically impossible or economically impractical.

Often, when determining the factors influencing any performance indicator characterizing the quality, Ishikawa schemes are used.

They were proposed by a professor at the University of Tokyo Kaoru Ishikawa in 1953 when analyzing various opinions of engineers. Otherwise, the Ishikawa scheme is called a cause and effect diagram, a fishbone diagram, a tree, etc.

It consists of a quality indicator characterizing the result and factor indicators (Fig. 3.6).

The construction of diagrams includes the following steps:

selection of a performance indicator that characterizes the quality of a product (process, etc.);

selection of the main reasons affecting the quality score. They must be placed in rectangles ("big bones");

selection of secondary causes ("middle bones") influencing the main ones;

selection (description) of the causes of the tertiary order ("small bones") that affect the secondary ones;

ranking factors according to their importance and highlighting the most important ones.

Cause and effect diagrams have universal applications. So, they are widely used in highlighting the most significant factors affecting, for example, labor productivity.

It is noted that the number of significant defects is insignificant and they are caused, as a rule, by a small number of reasons. Thus, by finding out the causes of the appearance of a few essential defects, almost all losses can be eliminated.

Rice. 6. Structure of the Cause and Effect Diagram

This problem can be solved with the help of Pareto charts.

There are two types of Pareto charts:

1. According to the results of activities. They serve to identify the main problem and reflect undesirable results of activities (defects, failures, etc.);

2. For reasons (factors). They reflect the causes of problems that arise during production.

It is recommended to build many Pareto charts, using various ways of classifying both the results and the reasons leading to these results. The best chart should be considered as one that reveals a few, essential factors, which is the goal of Pareto analysis.

The construction of Pareto charts includes the following steps:

The choice of the type of diagram (according to the results of activities or for reasons (factors).

Classification of results (causes). Of course, any classification has an element of convention, however, most of the observed units of any population should not fall into the "other" line.

Determination of the method and period of data collection.

Development of a data recording checklist listing the types of information collected. It must provide free space for graphical data logging.

Ranking of the data obtained for each tested feature in order of significance. The group "other" should be given in the last line, regardless of how large the number turned out to be.

Building a bar chart (Fig. 3.7).

Rice. 3.7. Relationship between types of defects and the number of defective products

Of considerable interest is the construction of PARETO charts in combination with a diagram of causes and effects.

Identification of the main factors affecting product quality allows you to link indicators production quality with any indicator characterizing consumer quality.

For such linking, it is possible to use regression analysis.

For example, as a result of specially organized observations of the results of wearing shoes and subsequent statistical processing of the data obtained, it was found that the service life of shoes (y) depends on two variables: the density of the sole material in g / cm3 (x1) and the adhesion strength of the sole with upper shoes in kg/cm2 (x2). The variation of these factors by 84.6% explains the variation of the resulting attribute (multiple correction factor R = 0.92), and the regression equation is:

y = 6.0 + 4.0 * x1 + 12 * x2

Thus, already in the production process, knowing the characteristics of the factors x1 and x2, it is possible to predict the service life of shoes. By improving the above parameters, you can increase the period of wearing shoes. Based on the required service life of shoes, it is possible to choose technologically acceptable and economically optimal levels of manufacturing quality features.

The most widespread practice is to characterize the quality of the process under study by evaluating the quality of the result of this process. In this case, we are talking about quality control of products, parts obtained in a particular operation. The most widespread are non-continuous methods of control, and the most effective are those based on the theory of the sampling method of observation.

Consider an example.

At the light bulb factory, the workshop produces light bulbs.

To check the quality of the lamps, a set of 25 pieces is selected and tested on a special stand (voltage changes, the stand is subjected to vibration, etc.). Every hour take readings about the duration of the burning of the lamps. The following results are obtained.

Introduction

Quality audit qualityaudit) - systematic independent verification to determine the conformity of activities and results in the field of quality with the planned activities, as well as the effectiveness of the implementation of activities and their suitability for achieving the set goals.

In the ISO 9000 series of standards, quality auditing is considered as a form of quality assurance. However, in domestic regulatory documents, the term "quality audit" is replaced by the term "quality control". In our opinion, such a substitution cannot be recognized as justified, since a quality audit is only one of the types of quality control.

Distinctive feature quality audit is its purely analytical nature. In addition, it is this term that makes it possible to overcome the psychological barrier associated with the prevailing idea in the country of verification as an activity, the inevitable consequence of which should be the identification of the perpetrators of violations of established requirements and the determination of a punishment for them. It is also important that the term "quality audit" is generally recognized among the world's specialists dealing with quality assurance problems. Characteristically, the term "auditor" in contrast to the term "quality audit" has already been established in the Russian normative documentation quality and does not cause any misunderstanding.

Quality audit activities should be distinguished from quality assurance activities such as quality control, quality surveillance and quality inspection.

Quality control is an activity involving the measurement, examination, testing or evaluation of one or more characteristics (for the purpose of calibration) of objects and comparing the results obtained with established requirements to determine whether compliance has been achieved for each of these characteristics.

Oversight quality - activity on continuous monitoring and auditing of the state of the object in order to ensure that the established requirements are met. Quality supervision activities carried out within the framework of a specific task are commonly called quality inspection. .

1. Types and purposes of audits

1.1 Internal audit

The internal audit of the quality system is designed to provide the management of the enterprise with objective and timely information on the degree of compliance of the activities in the quality system and its results with the established requirements. The main goal of internal audit should be considered to be the prevention of a decrease in the effectiveness and efficiency of the quality system in place at the enterprise.

The effectiveness of the internal audit of the quality system in the enterprise largely depends on its organization.

The organization of the internal audit of the quality system is the streamlining of the work of the internal audit service and departments of the enterprise in order to maintain the functioning of the quality system in accordance with the established requirements.

The internal audit of the quality system is designed to regularly check whether the activities within the quality system and the results of these activities are consistent with the planned activities. Internal audit timely brings to the attention of the management of the enterprise objective, fact-based information about the state of the quality system. In this regard, internal audit plays a key role in maintaining the quality system of the enterprise at the required level.

The objects of the internal audit of the quality system are its elements mediated in the activities of the enterprise's divisions in the implementation of the planned activities, i.e. the requirements of the quality system documentation.

The internal audit of the quality system is based on a number of organizational principles, the main of which should be considered uniformity, consistency, documentation, precaution, regularity, independence and openness.

The principle of uniformity means that the audit is carried out according to the procedure officially established by the management of the enterprise in order to ensure its orderliness, unambiguity and comparability.

The principle of consistency implies that planning and conducting specific audits on various elements (functions, works) of the quality system should be carried out taking into account their established structural relationship.

The documented principle assumes that the conduct of each audit is documented in a certain way in order to ensure the safety and comparability of information about the actual state of the audited object.

The precautionary principle establishes that each audit is planned, and the personnel of the audited unit are notified in advance of the purpose, time and methods of the audit in order to be most fully prepared and exclude the possibility of personnel evading the provision of all required data.

The principle of regularity determines that audits are carried out at regular intervals so that all elements of the quality system and enterprise divisions are subject to constant analysis and evaluation by the enterprise management.

The principle of independence means that the persons conducting the audit should not be directly responsible for the work being audited and should not depend on the head of the audited unit, which eliminates the possibility of bias in the audit results.

The principle of openness implies that the results of audits should be open, which ensures the "transparency" of the quality system for its users, consumers and external auditors.

From a methodological point of view, it is expedient to create an internal audit service already at the initial stage of the implementation of ISO standards, when the enterprise is just starting to implement the provisions of the standards, and not after the completion of these works. The creation of an internal audit service is evidence that the management of the enterprise understands the importance of quality audit and that such a service is in the interests of the enterprise.

The internal audit service of the quality system is staffed by two or more employees of the enterprise with higher education and at least two years of practical experience in the field of quality, who have undergone special training in relevant educational institutions or in training courses organized by the enterprise. The functions, responsibilities, powers and rights of auditors are established in their job description.

At enterprises where the creation of an internal audit service of the quality system in the form of a separate structural unit difficult, the audit of the quality system can be carried out by temporary groups specially formed for this purpose. At the same time, the duties of auditors are assigned (without exemption from the main work) to specialists of the enterprise departments most closely related to the development and operation of the quality system (quality assurance, standardization, metrology departments). These specialists are allowed to perform the duties of auditors only after their appropriate training, practical training and certification.

The quality audit service not only audits all departments of the enterprise involved in the work on the quality system, but is itself the object of such an audit. The management of the enterprise from time to time should receive information on the work of this service and evaluate it from the standpoint of the requirements of the quality system in force at the enterprise for quality audit.

A prerequisite for the effective operation of the service is the availability of appropriate organizational and methodological documents. Particular attention is paid to the development of methodological documents in order to:

Ensure methodological unity in the approaches, interpretations and assessments of auditors,

Ensure the work of auditors when conducting surveys, recording the results of observations, preparing reports,

Reduce the loss of time during the audit (here it should be noted that the lack of time practically does not allow even sufficiently experienced auditors to fully examine the object of the audit.

When forming the methodological support for the activities of auditors, suitable, but developed outside the enterprise, rules and methodological procedures can be used. Along with the documents, the methodological support includes various kinds of memos and teaching aids facilitating the work of experts.

In all cases, the organizational procedure for conducting internal audits of the quality system provides for the following main stages:

Audit planning,

Audit preparation,

Carrying out an audit

Analysis and generalization of audit results,

Development of corrective actions,

Monitoring the implementation of corrective actions.

1.2 External audit

An external audit is carried out by organizations external to the enterprise - the customer of the product or, for example, a certification body. In this case, when the audit is carried out by the customer of the product, it is called a second party audit.

The following forms of audit by the second party are practiced:

Full audit for compliance with a specific standard,

Partial audit concerning any aspect of the company's activities,

An auxiliary audit conducted by the customer in the presence of several applicants for the conclusion of the contract,

Audit of compliance with contract requirements.

An external audit conducted by an organization independent of the enterprise and the customer is called a third party audit. This type of audit is used for certification.

Of the considered types of quality audit, the third-party audit provides the highest degree of confirmation, which is due to its scale, depth and higher qualifications of the specialists conducting it.

The word "audit" itself means verification. Verification means that there is a certain standard against which verification is carried out. Usually such a standard is the international standards of the ISO 9000 series, but checks are also possible in relation to other systems of requirements, for example, fixed in contracts between the manufacturer and the consumer. Audit or verification plays a key role in the implementation and, most importantly, in maintaining quality systems for enterprises. A quality audit is a tool for assessing and developing corrective actions in an unbiased manner, and then for assessing how effective these actions are. Quality audit is a permanent mechanism for continuous monitoring of the state of the quality system since its inception.

It is known that any, even the most perfect, socio-economic system can begin to worsen its quality characteristics due to insufficient or untimely information about its functioning, obtained when managing the system. Insufficiency, untimeliness of information entails a lack of mutual understanding of the participants operating in the system and, as a result, the appearance of errors that have not been corrected in a timely manner.

The means to prevent deterioration of the system is to carry out regular and proper checks of its functioning. Such checks carried out by the enterprise itself are called internal. The introduction of ISO 9000 standards at domestic enterprises causes a number of organizational difficulties. In view of this, the role of internal audits is especially great at the initial stage of the functioning of quality systems. In accordance with the requirements of ISO 9001, the purpose of an internal audit is to assess the effectiveness of the quality system and the need for improvement or corrective actions.

The main purpose of the audit quality - checking the effectiveness of quality management existing in the enterprise. Quality assurance is based on the prevention of problems before they are detected. And where problems already exist, of particular importance are: early identification of the problem, the depth of its penetration into the activities of the organization and the search for the cause of its occurrence. The management of the enterprise is obliged to take measures to: identify problems and their causes; preventing the causes of problems. Quality problems generate consumer dissatisfaction, reduce profits, worsen the moral and psychological climate among employees.

Conducting a quality audit provides guidance feedback based on facts, giving him the opportunity and reason to make decisions to improve processes and improve product quality. The main purpose of an audit is to be beneficial to the service being audited. The main objectives of the internal audit are: determining the compliance of the elements of the quality system with the established requirements; identification of facts and causes of deviations from the specified modes of functioning of the elements of the quality system; development of proposals for the elimination of identified deviations and further improvement of the quality system.

W audit tasks in addition, it also includes a determination that: the product is suitable for its intended purpose; domestic regulations exist and apply; external regulations and legal requirements are strictly observed; deficiencies in the products or processes of the control system are identified; there is a mechanism for managing corrective and preventive actions that give positive results; information to identify and reduce risks is collected and analyzed; efficient and inefficient use of enterprise resources is monitored; the enterprise has standardized organizational practices and methods for improving processes and products.

To conduct audits or internal audits in enterprises, a documented procedure is developed and an audit (inspection) plan is drawn up, usually for a year. Audit plan - a description of the activities and activities for the audit. For each audit, an audit (inspection) group is provided, as a rule, under the leadership of a quality service employee (auditor) with the participation of qualified specialists. Audit (inspection) group - one or more auditors conducting an audit (inspection). For the objectivity of inspections, specialists who are not directly involved in the audited activity are involved in them.

There are three main types of quality audit: system audit, process audit(production) and product audit. Product audit can be carried out independently of other types of checks. It focuses on one or more types of products or services. When conducting process audit often a certain amount of time is devoted to auditing products. Such an audit is focused on the results obtained at the output of the process. System audit focuses on the entire quality assurance system as a result of the activities of management and the product or service program System audit therefore includes process audit. At the same time, it is planned to devote less time to auditing products. Differences in the types of audit due to their goals. The subject of the audit (its purpose) is determined by its scope (what needs to be included in the audit to solve these problems).

System audit - laborious and cumbersome process. It usually lasts two to five days (three days on average). It is carried out to find out, on the basis of objective evidence, whether the quality management system and plans of the organization are being implemented and whether they meet the set of requirements presented to them. To audit a system, it is necessary to set a goal and a scope. For a complete audit of the system, the work of two or three auditors is often considered sufficient. The number of auditors for each system is usually determined during the annual audit schedule.

A system audit may be carried out as a condition for attracting a new supplier before a decision is made to conclude a contract with him. The purpose of such a survey is to assess the potential supplier's ability to supply goods or services that meet the customer's requirements, and to determine whether any assistance (if any) is needed for the supplier to produce the required product or service. This survey is usually done as a general overview without going into details. With significant changes in the enterprise that affect product quality, system audits are performed, which are often referred to as revisions of the quality management system. This type of audit is necessary when there is a deterioration in product quality or changes in the management of the organization. System audits include and exceed process audits and product audits. They examine the interaction of all elements of the overall structure of the quality system and its impact on products or services.

Through a systems audit, an assessment of quality systems is given and it is checked whether the activities of the quality system are: established to the required extent, that is, whether the processes are defined and whether their methods are properly documented; carried out and whether there is evidence of their implementation, that is, whether the processes are fully implemented and implemented, as required by the documentation; how effective and fit they are, i.e. whether the processes are efficient enough to produce the expected results.

Process Audit is an important part of a quality system audit. During a system audit, one or more processes can be checked. An independent process audit is the most common and convenient, often bringing faster and more fruitful results. The reason is that the supplier will usually agree to the need for a change in a particular process rather than the need to deal with deep control system issues that are discovered as a result of a system audit.

Process audits are less extensive than system audits; usually focused on one or more specific production processes; require less planning than a system audit; can be very useful in improving the process under consideration; less formal than quality system audits, they can be completed in one to several days, it depends on the scope of the audit, on the various processes, production lines, standards requirements considered.

Typically, these audits require fewer auditors than system audits. The scope of the audit will help determine the number of auditors required. For example, a simple internal audit would require one auditor, while an external audit would require two or more. This audit certifies compliance with standards, methods, procedures or other requirements.

Product audit - e it is an assessment of the final product or service, its "fit for purpose" in comparison with the specified requirements. Product audit is focused on the consumer. It may be performed by at least one auditor, but may require large group auditors (or even several groups, in case the product or its performance must meet the requirements of environmental protection or other safety requirements). Product audits can be performed: at the manufacturing plant: for example, at the loading dock, when goods are tested and inspected before shipment, or at the exit of a production line, within the enterprise, when the results of a technological process are considered, each as an input to the next process (or internal consumer); outside the company: however, the above audit examples can be carried out at the customer's site or with the participation of the end user.

Quality audits are formalized, systematized and independent. Their results are based on facts. The effectiveness and completeness of an audit largely depend on the qualifications and experience of the auditor(s). Auditor - a person who has the competence to conduct an audit (inspection). The auditor is based on the following basic assumptions:

- Auditors should discover facts, not just fix errors.

Audits should not be conducted covertly (secretly).

The auditor is not a controller, but an assistant for the audited.

Quality checks are carried out by persons who are not directly responsible for the areas being checked. At the same time, interaction with the personnel of the inspected sites is desirable. One of the purposes of quality assurance is to assess the need for improvement or corrective action. A distinction should be made between auditing and quality surveillance or control activities carried out for the purpose of process control or product acceptance. Quality checks (audits) can be carried out to meet internal or external needs.

The frequency and timing of internal audits are established by the head of the enterprise based on the results of the functioning of the quality system and the need to improve it. It is recommended that internal audits be carried out on an ongoing basis, with a certain section of the quality system being audited every month (the same object no more than once every six months).

Scheduled audits systems are conducted according to a previously established annual plan that ensures that all quality elements encountered in the unit/process are assessed at regular intervals, at least once a year. At the same time, it is taken into account that these intervals ensure the normal functioning of the quality system. The annual audit plan is drawn up by the Quality Commissioner in agreement with the departments and approved by the management of the enterprise. The annual audit plan may include: units, departments or processes audited, important elements of quality, audit intervals / times. The organization of internal audit provides for the consistent implementation of the following activities: preparation for internal audit; conducting; analysis and generalization of audit results.

Conducting an audit (checks) carried out in the following sequence.

Before conducting an internal audit, an introductory conversation should be held with the personnel responsible for the process and the employees accompanying the auditors. . It is recommended that the head of the audited unit also participate in the audit. The introductory conversation should explain the purpose and purpose of the audit. At the same time, the auditor should explain and agree on his approach and say what documents and records are necessary for internal audit. With this introduction, it is recommended to recall the results of the last audit.

Any internal review follows a predetermined plan that should be as flexible as possible, allow for changes in focus based on the information obtained during the review, and ensure efficient use of available workforce. If in the course of familiarization with the audit plan it turns out that the audited official objects to any points of the audit plan, then these objections are immediately brought to the attention of the chief auditor. controversial issues resolved between him and the verifiable.

The collection of materials (initial data) of the internal audit is carried out by the members of the working group through surveys or personal interviews with the respondents and recording observations of the actual state of work in the audited areas. The degree of compliance of the actual state of work with the requirements established by the documents of the quality system is carried out according to a specially developed block-questionnaire, which covers all issues of activity within the framework of the enterprise's quality system and which are the objects of internal verification. During the internal audit, it is possible to use additional work not provided for by the plan and the block questionnaire, the need for which may arise during observations. Audit observations (checks) - the result of the assessment of the audit evidence (verification) depending on the audit criteria. Audit Criteria (Checks)- a set of policies, procedures or requirements that are applied in the form of references. Evidence of an audit (verification) - a record, statement of fact, or other information related to the audit (verification) criteria that can be cross-checked. Objective evidence- data confirming the existence or truth of something.

Analysis and generalization of the results of the internal audit. After completing the work related to the collection of information on the state of the objects of internal verification, the working group analyzes this information in order to identify actual or alleged inconsistencies and develop appropriate recommendations. Based on the results of the internal audit, a formalized assessment of the state of the elements of the quality system can be drawn up. To this end, all received working group Answers to questions are evaluated according to the following conditional scale:
2 points - a completely positive answer; 1 point - although the answer is positive, however, there is a possibility of inconsistency on the issue under consideration; 0 points - the answer is negative.

A qualitative assessment of the state of the object of verification can be attributed to one of the following three options: good - answers to questions characterizing the object of verification are rated at 2 points; satisfactory - answers to all questions characterizing the object of verification are rated 2 and 1 points; unsatisfactory - answers to all questions characterizing the object of verification are rated at 0 points.

Each discrepancy identified by the audit team should be corrected immediately to enable additional follow-up to be carried out more effectively. Necessary improvement actions that cannot be immediately implemented should be agreed with the management of the unit and documented in the form of corrective actions. . Their suitability for achieving the goals must be justified.

Final conversation. When conducting a closing conversation, the positive aspects should be noted first. Only then are the identified deviations discussed and a conclusion made about the potential for improvement. If necessary (together with the person responsible for the process), both the improvement measures and the timing and responsibility for the implementation of these improvements are discussed.

Audit report includes the following: participants, deadlines, relevant quality elements, unit/process being audited, documented results of the audit, indication of improvement activities. The audit report must be signed by the auditor, the head of the audited unit. The distribution of the audit report is carried out by the following services of the enterprise: the management of the enterprise, the head of the audited unit or process, the quality officer, all auditors.

Conclusion on the results of the audit (inspection) - audit output provided by the audit (review) team after reviewing the audit objectives and all observations. Audit findings are the result of evaluating the collected audit evidence against the audit criteria.

Qualification criteria are established and additional methods are described for assessing the extent to which the auditor fulfills the necessary criteria and how his abilities should be maintained in order to work as an auditor. Organizations that conduct frequent quality audits should have guidance to guide the entire process and apply the guidelines outlined in the program in organizing and supporting the governance functions of audit programs.

At present, in the conditions of market relations, when all enterprises and organizations are granted the right to independently enter foreign market they face the challenge of assessing the quality and reliability of their products. international experience testifies that essential tool Certification is a guarantee that product quality meets the requirements of normative and technical documentation.

Certification in the generally accepted international terminology is defined as the establishment of conformity. National legislative acts different countries specify: matching what is installed and who sets this match. Quality system certification is a third party (independent) activity proving that it provides the necessary assurance that a properly identified quality management system complies with ISO 90001 standards. Quality system assessment is a comparison of factual information about the quality system (quality system elements) of an enterprise - the applicant with the requirements of the standard.

The results of certification of quality management systems are used in: certification of products; conclusion of agreements (contracts) for the supply of products; choice government bodies enterprises to place government orders; determination by banking organizations of the expediency of lending to enterprises; determination by insurance organizations of expediency of insurance of enterprises; in other cases, when it is necessary to confirm the ability of the enterprise to consistently produce products of good quality.

The advantages of enterprises from certification of quality management systems: without a certified quality management system, goods cannot be sold on a foreign market; in accordance with the decisions of the EU and other international communities, from 01.01.93, products supplied to the international market are required to have a certificate for their quality assurance system, the absence of this certificate leads to a multiple reduction in prices for the products supplied compared to the world price level; in the presence of a certificate, the price of exported products increases significantly; an effective quality management system can be a reliable guarantee of product safety; The economic benefit of using quality management system certification allows you to reduce the amount of expensive testing and inspection control, certification of quality management systems and production is all the more appropriate, the more types of products the company must certify, the higher the requirements for their safety and the more expensive certification tests.

The enterprise to the certification body together with the application and cover letter sends: a questionnaire for conducting a preliminary check of the quality system, a general quality manual, information data on product quality, a declaration of conformity of the quality system. At the request of the certification body, other information and data about the enterprise and the quality system can also be submitted.

Based on the results of the first stage, the certification body draws up a conclusion, which indicates the readiness of the enterprise and the feasibility of carrying out the second stage of work on certification of the quality system, or reveals the reasons for the inexpediency or impossibility of carrying out work on the second stage. If during the work of the second stage the certification body detects a discrepancy between the quality system and the requirements of the standard, then the term for its revision is determined and the term for re-inspection is set. With a positive decision, the certificate is issued for a certain period, usually this period is limited to three years.

It is known that even a perfectly working quality system can become ineffective over time. Therefore, regular checks, analysis and evaluation of the quality system are required. The management of the enterprise must ensure that an independent analysis and evaluation of the system is carried out - an internal audit. During external verification, in accordance with the requirements of ISO MS, not only the documentation and management organization are checked, but also the entire technical base of a specific "product, i.e. the condition technological equipment, metrological support of production, means and methods of control. The motivation for the introduction of MS ISO is the ability of the enterprise to expand export opportunities. The management of an increasing number of enterprises is convinced that profitable deals with foreign partners can be concluded if they are presented with a certificate for a quality system and given the opportunity to verify its ability to ensure stable output of products of a given quality. With the transition to a developed market economy, the implementation of ISO MS should become a recognized necessity for every enterprise, since without modern system quality to achieve economic viability is impossible.

The results of certification of quality systems (industries) are used in:

Product certification; conclusion of agreements (contracts) for the supply of products;

Selection by state bodies of enterprises for placement of state orders;

Determination by banking organizations of the expediency and policy of lending to enterprises; determination by insurance organizations of expediency of insurance of enterprises; in other cases, when it is necessary to confirm the ability of the enterprise to consistently produce products of good quality.

Without a certified quality system, a product cannot be sold on a foreign market at all. So, in accordance with the decisions of the EU and other international communities from 01.01.93, products supplied to the international market are required to have a certificate for a quality assurance system. The absence of this certificate leads to a multiple reduction in prices for the supplied products compared to the world price level. With a certificate, the price of exported products increases significantly. The product is certified with increased safety requirements. This is typical, for example, for the aviation industry or the industry producing equipment for nuclear power. An effective quality system can be a reliable guarantor of product safety. The international certification system, to which Russia has joined, introduces rules for assessing quality systems and organizing production. The certification body seeks to increase the degree of reliability of its conclusion when issuing a certificate and thereby reduce both its risk of losing credibility and the risk of the customer (consumer) entering into a contract with an unreliable partner. Especially often this approach is used abroad. Thus, the national standardization body AFNOR (France) conducts certification for the NF mark of conformity only with an assessment of the quality system. Since 1993, such tactics have been adopted by the British firm Lloyd Register and the German Det Norske Veritas, which are actually international organizations for the certification of products and quality systems. It is economically beneficial to use quality system certification, which allows reducing the volume of expensive tests and inspection control. This is explained by the fact that the certification of production of various products at one enterprise has common elements of verification, and therefore their simultaneous certification costs the enterprise less than sequential certification of each type of product. Certification of quality and production systems is all the more appropriate, the more types of products the company must certify, the higher the requirements for their safety and the more expensive the certification tests.

In some cases, certification of quality systems at the request of the applicant (and with the appropriate preparation of the certification body) can be carried out for compliance with another document determined by the applicant. Certification of production is carried out according to methods developed in relation to specific types of production.

The subjects carrying out activities for the certification of quality systems and production in the Russian Certification System (hereinafter referred to as the System) are:

Federal Agency for Technical Regulation and Metrology and its subordinate organizations; Bodies for certification of quality systems.

The objects of verification during the certification of quality systems are: management and quality assurance activities; production system; product quality.

The certification body in the System can be an organization that has competence and independence and is accredited for this activity within the System. Certification bodies carry out: certification of quality systems and production facilities of the enterprise; registration and issuance of certificates; development of inspection programs for specific enterprises for certification purposes; inspection control of certified quality systems and production facilities; control over the correct use of certificates. Work on certification of quality systems and production is carried out by expert auditors registered in the State Register of the System. Inspection control over certified quality and production systems is carried out at least once a year during the entire period of validity of the certificates by the bodies that carried out the certification and issued the certificates. Unscheduled inspection control can be carried out in the following cases: information is received about claims to the quality of products of an enterprise that has a certificate of conformity for the quality (production) system; significant changes in product design or production technology; significant changes in the structure or personnel enterprise with a certificate of conformity. With positive results of certification of the quality system (production), the enterprise is issued a certificate of the established sample. The certificate of conformity for the quality system contains a single Mark of Conformity of the quality system, as well as a distinctive sign of the body conducting the certification and issuing the certificate. The certificate of conformity for the quality system is also a document confirming the certification of production, since the assessment of production is an integral part of the certification of quality systems. The manufacturer, which has received a certificate of conformity for the quality system, has the right to use the certificate and the Mark of Conformity for advertising purposes.

The certificate of conformity for the quality system (production) is valid for no more than three years from the date of registration. The validity period of the certificate can be extended if the enterprise confirms the compliance of the quality system (production) with the requirements established in the System. The validity of the certificate may be canceled or suspended by the decision of the authority that issued the certificate in cases where: information is repeatedly received about the non-compliance of products with the required quality level; products and the technology of its manufacture have undergone changes, which led to a decrease in quality; during the inspection control, a discrepancy between the quality system (production) was found, the certificate expired and the enterprise did not issue its extension.

When certifying quality systems (productions), the following basic principles are observed: voluntariness, objectivity of assessments, reproducibility of assessment results, confidentiality, information content. Voluntariness is manifested in the fact that certification of quality systems and production is carried out only at the initiative of the enterprise, if there is an application from it. The exception is cases when the assessment of the quality system or the state of production is provided for by the scheme of mandatory product certification. The applicant has the right to apply with an application to any certification body accredited in the System. The objectivity of assessments is achieved: by the independence of the certification body and the experts-auditors involved by it from the applicant or other parties interested in the certification of the quality system (production) of the enterprise; competence of expert-auditors (an expert-auditor must be certified for the right to conduct certification of quality systems with subsequent periodic evaluation of his activities); certification by a commission of expert auditors of at least two people, headed by the chief expert auditor. The reproducibility of the results implies that, under regulated conditions, the main results of the verification work can be obtained again (repeated). Reproducibility is ensured by: the use of techniques based on uniform requirements; documentation assessment and certification results; a clear organization of the system of accounting and storage of documentation by the certification body.

The application of the principle of confidentiality is caused by the fact that the information received by the experts in the course of verification may be a trade secret. Therefore, each participant in the verification process confirms in writing their obligations to maintain the confidentiality of information. Informativeness is provided, as in the case of product certification, by informing interested organizations and persons about certified expert auditors, issued certificates and cancellation of certificates, accredited certification bodies. As already noted in Chap. 3, - the official source of information on the listed issues is State Register Russian system certification.

In the process of certification of the quality system, two stages can be distinguished: preliminary verification and evaluation of the quality system; final verification, assessment and issuance of a certificate of conformity of the enterprise quality system of the relevant standard. Each of these stages contains a specific scope of work. Enterprises applying for quality system certification should send to the certification body along with the application and a cover letter: a questionnaire for conducting a preliminary check of the quality system, a general guide to the quality of the quality system, information data on product quality - information on claims, losses from marriage, the results of certification previously carried out at the enterprise, product testing, a declaration of conformity of the quality system, an invoice for payment for the first stage of testing the quality system. At the request of the certification body, other information and data about the enterprise and the quality system can also be submitted.

Based on the results of the first stage, the certification body draws up a conclusion, which indicates the readiness of the enterprise and the feasibility of carrying out the second stage of work on certification of the quality system, or reveals the reasons for the inexpediency or impossibility of carrying out work on the second stage. If the conclusion is positive, when signing the contract, the deadlines for the work on the second stage - the final inspection and assessment of the quality system are set. If during the work of the second stage, the certification body detects a discrepancy between the quality system and the requirements of the relevant standard, then together with the enterprise, the term for its revision is determined and an approximate period for re-inspection is established.

The development of certification activities in the industrial sphere of the domestic economy created the prerequisites and necessitated the creation of a set of rules for the accreditation of various objects (certification bodies, testing and measuring laboratories).
For these purposes, a set of requirements was formed that are applied in the Russian Federation to the systems of accreditation of objects that carry out conformity assessment, including testing, measurement and certification in the mandatory (legally regulated) and voluntary areas.

The international practice of certification is aimed at eliminating technical barriers that arise during the certification of products and ensuring its unimpeded promotion on the markets. the largest international organization is the General Agreement on Tariffs and Trade (GATT). The agreement contains special recommendations for its participants (about 100 countries) in the field of standardization and certification. The participating countries of the Conference on Security and Cooperation in Europe (CSCE) in their final documents following the meetings in Helsinki (1975) and Vienna (1989) noted the need for cooperation in the field of certification and its use as a means to promote convergence and expansion trade relations of countries. The leading place in the field of organizational and methodological support of certification belongs to ISO, within which the Certification Committee (CERTICO) dealt with these issues. In 1985, in connection with the further development of work, it was renamed the Committee for Conformity Assessment (CASCO), ISO 176 committee. .