- •"Quality management system" for students of specialty
- •5В073200- «Standardization, certification and metrology»
- •Content
- •1. The main objective of studying of discipline of "Quality management system" and a task solved in the course of studying
- •2 Essence of quality as object of management
- •2.1 Concept of quality
- •4 Qualimetry
- •Table 1
- •Table 2 - Classification of indicators of quality
- •1 Main stages of development of control systems of quality
- •1.1 Formation and development of quality management. The factors influencing quality of production
- •1.2 The international standards on control systems of quality of production
- •2 General quality management is based on the following basic provisions:
- •3 Principles of tqm
- •5 Iso 9000 and tqm Standards
- •Iso 9000 and tqm standards
- •2 Standard algorithm of introduction of qms includes the following stages:
- •I claim:
- •Representative of the management
- •Interests of employees:
- •Interests of the enterprise:
- •Interests of suppliers:
- •Examples of the purposes in area of quality and Plans of quality
- •The purposes in area of quality of jsc Kaztsink on 200_ g.
- •Chief of of of f.I.O.
- •Director of az f.I.O
- •I claim:
- •Plan of quality of jsc Kaztsink
- •4 Responsibility and powers and exchange of information
- •Appendix a The terms and definitions relating to documents
- •Appendix b
- •1 Concept about processor approach to a control system at the enterprise (organization)
- •4 Cals Standards
- •3.3 Advantages of cals technology
- •4 Cals Standards
- •Elements of systems of management which benefit from integration
- •Ims is effective?
- •Process
- •Purpose
- •4 Methodology of statistical quality control
- •4.1 Mechanism of statistical product quality control
- •4.3 A role of statistical methods in management of productions
- •4.3.1 Control leaves
- •4.3.2 Pareto's analysis
- •4.3.3 Chart of the reasons and results
- •Control cards
- •3 Requirements to resources
- •5 Criteria of productivity of process
- •Methods of monitoring and management of process
- •The identified risks and measures for their exception
- •6 Working procedures
- •Appendix b Output documents (the documents and messages which appeared as a result of actions within process)
- •Appendix 3 Output documents (the documents and messages which appeared as a result of actions within process)
- •Matrix of distribution of responsibility of participants of process
- •Appendix d The requirements of st rk iso 9001:2009 and the requirement of the organization considered in process
- •Appendix e
- •Appendix Zh
- •List of internal auditors of qms of the enterprise
- •Appendix I
- •Personal leaf of the accounting of the auditor No. ____
- •(Signature, Surname)
- •Auditor questionnaire
- •Appendix l
- •Iso 9001 code: 4.2.4, 7.1, 7.2.3, 8.2.2, 8.3 Plan of audit
- •Appendix l
- •Iso 9001 code: 4.2.4, 7.1, 7.2.3, 8.2.2, 8.3 Plan of audit
- •Appendix m
- •Leaf of the revealed discrepancies No. ____
- •Analysis of discrepancy
- •Appendix n
- •Report on audit
- •Iso 9001 code:
- •The note - by italics the example of filling of this form is shown. Appendix p
- •Iso 9001 code:
- •8 Certification of quality systems
- •9 Tell about the identified risks and measures for their exception when carrying out internal audit
2 Standard algorithm of introduction of qms includes the following stages:
1. The order on the beginning of introduction of QMS at the enterprise is issued.
2. The Policy of the enterprise in the field of quality is developed.
3. Fundamental standards of the enterprise in the field of quality are developed.
4. The Quality manual of the enterprise is developed.
5. Internal audits of the developed QMS are booked.
6. On the basis of the revealed discrepancies according to the quality system the correcting events are held.
7. On the basis of the held correcting events changes are made to normative documents of the quality system.
8. Introduction of system of management is carried out.
9. Certification of the quality system by external body for certification is carried out.
1. At introduction of QMS all developed documentation is approved by the order on the enterprise. Begins the first stage of introduction of QMS with development and the adoption of the order on work on QMS. The form of the order and its registration is carried out according to the established rules at the enterprise. The documentary procedure regulating all stages of registration, coordination and the approval of the documents relating to organizational administrative documentation (orders, service records, statements, etc.) is developed for management of management process organizationally - administrative documentation at the enterprise
2. The top management of the organization has to provide definition, documentary registration and adoption of policy in the field of quality, including tasks of quality and the obligations for quality. When developing policy in the field of quality the top management has to consider:
- possibilities of future improvement necessary for success of the organization;
- the planned level of satisfaction of the consumer;
- possibilities of professional growth of the personnel of the organization;
- inquiries and expectations of all interested parties (consumers, staff of the organization, society, shareholders, investors)
- necessary resources;
- contribution of suppliers and partners.
Effectively formulated and reported policy in the field of quality has to:
- to be the organization coordinated with the forecast of the future;
- to be under construction so that the purposes in area of quality were clear in all organization;
- to show commitment of the top management to the obligation in quality and security with adequate resources for its achievement;
- to be focused on continuous improvement and on satisfaction of consumers.
The stable ensuring quality of production, or services satisfying consumers has to be the main direction of policy of the organization in the field of quality.
Intentions of the management of the organization to provide satisfaction of requirements of all interested parties which treat, except consumers, the staff of the organization, suppliers of materials and components, investors, shareholders, etc. have to be reflected in policy in the field of quality.
It is necessary to reflect commitment of the management to provide activity of the organization so that production, or performance of services, and also products did not cause damage to environment.
Increase of competitiveness of production (services) and export opportunities of the organization, gain of new sales markets can be one of the directions of the accepted policy in the field of quality.
The solution of social problems of staff of the enterprise and society due to release of competitive production (services) and minimization of risks and losses owing to production of inadequate quality can be reflected in policy in the field of quality.
Examples of separate provisions from policy on quality of the advanced firms:
Rolls Roys firm (Great Britain): "The policy of firm consists in supporting such level of quality and reliability of the products and services which, by recognition of consumers, none of competitors cannot be surpassed".
Heva Mitsubishi Indastris firm (Japan): "Quality above all, any compromises in the field of quality".
3 Development of fundamental standards of the enterprise in the field of quality
Art. 4.1 of ISO 9001:2008 "General requirements" demands from the organization (enterprise) of establishment, documentation, introduction and maintenance of quality management system and continuous increase of its efficiency according to requirements of the international standard". Development of the following documents belongs to fundamental standards of the enterprise (organization):
a) the documentary statement of policy is also more whole than quality;
b) quality manual;
c) the documentary procedures demanded by the international standard;
d) documents necessary for the organization for ensuring efficiency of planning, work and control of its processes;
e) the records demanded by the international standard.
ISO 9001:2008 specifically demands from organization "documentation of procedures" for the following six kinds of activity:
- 4.2.3. Control of documents
- 4.2.4. Control of records
- 8.2.2. Internal audit
- 8.3. Control not of the corresponding production
- 8.5.2. Remedial actions
- The warning actions
These procedures have to be controlled according to requirements
Art. 4.2.3. ISO 900:2008.
Depending on what processes at the enterprise are considered as the main, them also make out in the form of documentary procedures.
4 Development Quality manual of the enterprise (organization)
The quality manual is the generalizing document of quality management system of the enterprise and has to contain the description of policy in the field of quality, basic provisions of QMS, and also data on the enterprise and its activity in the field of quality.
The quality manual is developed to provide:
- effective introduction of quality management system;
- a statement of policy of the enterprise in the field of quality;
- effective management of processes in quality management system;
- standard basis for audit of quality management system;
- stability of functioning of quality management system in the changing conditions;
- preparation of the personnel of the enterprise in the field of ensuring quality;
- demonstration of compliance to QMS of ST RK ISO 9001 by the enterprise in contract conditions.
The quality manual as a rule contains:
- prolog;
- a statement of Policy of the enterprise in the field of quality;
- purposes in area of quality and tasks of the organization;
- characteristic of structure of the enterprise;
- distribution of responsibility and powers, the sections describing the organization of works in quality management system;
- sequence and interaction of processes of quality management system, offer on revision and correction of a quality manual.
Separate requirements of QMS can be excluded if they cannot be applied from - for features of production, requirements of consumers, legislative requirements.
Exceptions are limited to requirements to processes of life cycle of production (the section of 7 ST RK ISO 9001).
Exceptions have to be defined in a quality manual.
Legislative requirements can be applied in all cases even if the area is limited. Requirements of QMS can be strengthened for the purpose of satisfaction of legislative requirements.
5 Carrying out internal audits
After development, introduction and functioning of QMS at the enterprise (organization) are carried out internal inspections (audits) for detection of discrepancy and the analysis of the developed control system.
"Internal audit" is the process purpose:
- planning of internal audits; carrying out objective and independent internal audits of QMS;
- an assessment of compliance to the carried-out activity to requirements of the ST RK ISO 9001:2009 standard, Policy of the enterprise in the field of quality, Quality manuals, other processes and procedures, and also the standard documentation used by the checked organization (division, department, group, the top management);
- an assessment of compliance to the carried-out activity to requirements of the Consumer;
- documentary registration of the conclusion by results of audit;
- use of results of audit for maintenance of procedures and processes of QMS in working order and for improvement of procedures, processes of QMS and Quality management system in general;
- improvement of methods and procedures of carrying out internal audits;
- continuous increase of competence of internal auditors.
Constantly carried out internal checks and works on identification and elimination of discrepancies provide confidence of the consumer as production of the enterprise.
- internal audits (checks) can be planned and unplanned.
- planned audits are booked according to the schedule of carrying out the internal audits made and approved till December 20 of the current year the next year.
- unplanned audits are booked out of the annual schedule of carrying out internal audits according to the indication of the top management and the representative of the management in the following cases:
a) on request of consumers;
b) changes of organizational structure of the organization;
c) modification of QMS;
d) preparation for certification of QMS;
e) possibility of emergence of problems with quality;
- by inquiries of the organization additional internal audits can be booked.
The representative of a quality manual is responsible for carrying out internal checks. Belongs to its duties:
- definition of the checked organization, areas and the purpose of audit;
- development and the statement at the top management of the annual schedule of carrying out internal audits;
- development and the statement at the top management of the schedule of unplanned internal audits;
- organization of planning and carrying out internal audits;
- operating control and assessment of results of internal audits;
- control of timely registration of reports on audit;
- control of works on development and performance of the correcting and/or precautionary measures for elimination of the discrepancies revealed during audit;
- control of registration and storage of documents on internal audits;
- methodical help to auditors;
- organization of discussions of results of audits;
- permission of the possible conflict situations arising during internal audits;
- preparation of data on results of audits for the analysis from the top management and for process of continuous improvement.
The service of quality of the enterprise annually forms structure of the experts capable to carry out internal quality checks. The structure of these experts is approved by the order on the enterprise and made out in a matrix of distribution of responsibility
6 On the basis of the revealed discrepancies according to the quality system the correcting events are held
The process purpose the correcting actions is detection of discrepancies, planning, performance and an assessment of the correcting measures on the basis of the approved normative documents with observance and implementation of requirements of the Consumer and the ST RK ISO 9001:2009 standard
The correcting actions are an obligatory component of an administrative cycle of all processes of QMS of the enterprise (organization) and are undertaken for the purpose of elimination of the reasons of discrepancies for the prevention of their repeated emergence
Stages of procedure of the correcting actions are:
- detection of discrepancies and their registration;
- analysis (research);
- elimination of discrepancies
Stages of procedure of the correcting actions are:
- detection of discrepancies and their registration;
- analysis (research);
- elimination of discrepancies
- an assessment of need of development of the correcting actions;
- development of measures for an exception of the reasons;
- implementation of measures;
- an assessment of efficiency of the taken correcting actions.
Procedures of the correcting actions can be initiated:
- at the level of a workplace - the contractor;
- at the level of process - owners of processes;
- at the level of QMS - the officials responsible for the QMS procedures for implementation of requirements of ST RK ISO 9001:2009, the Representative of the management, the top management.
Problems which cannot be eliminated at the level are transferred for the decision to higher level. Account of discrepancies is kept by owners of processes in whom they are shown also responsible for the QMS procedures for implementation of requirements of ST RK ISO 9001:2009.
The service of quality conducts the general database of the problems and discrepancies which are in study and traces all cycle of the works provided by the present standard from the moment of registration of discrepancy before completion of realization of the correcting actions and recognition by their productive
7 On the basis of the held correcting events changes are made to normative documents of the quality system
8 Introduction of system of management Is carried out
9 Certification of the quality system by external body for certification Is carried out
Control questions:
1 The representative of a quality manual - function, power and the requirement
2 Standard algorithm of introduction of QMS at the enterprise (organization)
3 Requirements imposed to development of Policy in the field of quality
4 training of the personnel is for what purpose provided
5 What documents of the enterprise in the field of quality belong to fundamental standards
6 Purpose of the Quality manual
7 Call six compulsory documentary procedures demanded by the ISO 9000 standard
8 Structure of documentary procedure
9 Structure of the Quality manual
10 Give definition to concepts internal audit, the correcting actions
11 Stages of carrying out internal audit
12 According to what standard certification of the developed QMS is carried out
Literature
1 СТ РК ИСО/ТО 10013-2008. Система менеджмента качества. Руководящие указания по документированию, Астана, 2008 год;
2 Методические рекомендации по разделу 5 «Ответственность руководства» СТ РК ИСО 9001-2009 «Система менеджмента качества. Требования», Астана, 2002;
3 Методические рекомендации по разделу 6 «Менеджмент ресурсов» СТ РК ИСО 9001-2009 «Система менеджмента качества. Требования», Астана, 2002;
4 Руководство по пункту 1.2 «Применение» ИСО 9001:2000, Астана, 2001;
5 Методические рекомендации по применению принципов менеджмента качества, Астана, 2002;
6 Руководство по требованиям ИСО 9001:2000 к документации, Астана, 2002;
7 Методические рекомендации по использованию типового алгоритма при внедрении систем качества в соответствии с ИСО серии 9000 на предприятиях Республики Казахстан, Астана, 2001;
8 СТ РК 3.15.1-2006. Сертификация систем менеджмента качества. Основные положения, Астана, 2006;
9 В.И. Логанина, А.А. Федосеев. Системы качества. Учеб. пособие для вузов.- М., 2008.
Lecture 6
Theme: Policy of the organization in the field of quality. Purposes and an organization task when developing policy. Providing the obligation on development and QMS introduction. Policy formulation
Lecture plan:
1 Main objectives of Policy in the field of quality
2 Requirements to Policy in the field of quality
3 Standard examples of Policy in the field of quality
According to ST RK ISO 9001-2009 Requirement of the Politician in the field of quality these are the general intentions and activities of the organization in the field of quality which are officially formulated by the top management.
The policy in the field of quality is the main document QMS of the organization showing the official attitude of the top management of the organization to questions of quality of the made production, the rendered services.
The top management has to provide, that policy in the field of quality:
- answered the purpose of the organization;
- included the obligation to conform to requirements and constantly to improve productivity of quality management system;
- created bases for statement and the analysis of the purposes in quality area;
- it was brought to the attention of the personnel of the organization and it is clear to it;
- it was regularly analyzed on constant suitability.
The documentary policy of quality has to be controlled according to requirements of item 4.2.3 of the ISO 9001-2000 standard. The top management needs to use policy in the field of quality as a control facility the organization for the purpose of improvement of its activity.
It is necessary to achieve that the policy in the field of quality was the equal and coordinated part of the general policy and strategy of the organization.
The policy in the field of quality has to be capable to show that it is based on eight principles of quality management. For example, how the policy allows the organization to be focused on the customers how it allows to involve people.
Approach to formation of policy in the field of quality has to be the following:
- define mission of the organization;
- use 8 principles of quality management for a policy assessment;
- formulate the measured purposes directly from mission of the organization;
- use 8 principles of quality management for check of coherence and completeness of the purposes;
- include each process and, therefore, each function in QMS;
- clear communication between mission, the purposes and processes.
2 When developing policy in the field of quality the top management should consider:
- level and type of future improvements necessary for successful work of the organization;
- the expected and desirable degree of satisfaction of consumers;
- growth of employees of the organization;
- requirements and expectations of other interested parties;
- the resources necessary for an exit for a framework of requirements of the ISO 9001-2000 standard;
- potential contribution of suppliers and partners.
The policy in the field of quality can be used for improvement, if it:
- it will be coordinated with the forecast and strategy of the top management for prospects of the organization;
- allows to understand and carry out the purposes in the field of quality in all organization;
- confirms commitment of the top management to quality and ensuring achievement of the objectives with adequate resources;
- helps to explain the obligation concerning quality in all organization at accurate leadership of the top management;
- includes the continuous improvement connected with satisfaction requirements and expectations of consumers and other interested parties;
- it is effectively formulated and brought skillfully to the attention of everything the personnel.
The policy in the field of quality should be analyzed periodically.
In view of the fact that the Policy explanation in the field of quality and acquaintance with it, is the obligatory requirement of the standard, each employee of the enterprise has to confirm acquaintance fact, it is desirable in writing (the minutes of chair, meeting, etc.).
3 Standard examples of Policy in the field of quality of some enterprises it is given below.
Example 1: "Our policy is production, completely satisfying to expectations of our consumers. That to execute it, we recognize that each worker is responsible for quality, and each worker has to participate in improvement of quality and productivity of release of goods and services".
Example 2: "Our enterprise specializes on design, production and installation of equipment, delivered generally on the markets of high technologies.
The enterprise sees a main goal in representing the equipment and the related services meeting the highest requirements and expectations of consumers.
The enterprise developed for achievement of this purpose and supports in working order the system of ensuring quality conforming to requirements of the ISO 9001 standard. Compliance of results of work of the enterprise to requirements of the contract is confirmed by objective data on quality. Fundamental principle of activity of the enterprise: quality above all.
Example 3: The full text of Policy in the field of quality of JSC PK Yuzhpolimetall:
