Enterprise standard for the effectiveness of QMS processes. Methodology for quantitative assessment of the effectiveness of the functioning of the QMS
MINISTRY OF EDUCATION OF THE REPUBLIC OF BELARUS
EE "BELARUSIAN STATE ECONOMIC UNIVERSITY"
Department of technology of the most important industries
ABSTRACT
discipline "Technical regulation
processes and products"
on the topic of: "Analysis of the methods of the effectiveness of processes
quality management systems"
FM student of the 5th year
HCT groups
Checked by Panevchik V.K.
APPENDICES…………………………………………………………………. 12
INTRODUCTION
The struggle for the consumer, the aggravation of competition have a significant impact on changes in the "philosophy" of doing business in the world: the problem of quality has come to the fore. Not declaring the quality of products, works and services, but namely quality assurance, constant work on improving consumer properties, improving production technology. Only quality products and services make the company's consumers turn to it again and again, because many consumers consider an increase in quality as something more important than a decrease in price. To win the trust of consumers and, moreover, to keep it is the cherished dream of both the "generals" and the "captains" of the business.
Some managers believe that meeting customer quality expectations leads to higher costs, which in turn lower profits or increase prices. This position is not at all unreasonable, at first glance: after all, to improve quality, it is necessary to tighten the verification and rejection of low-quality products, which leads to inevitable loss of time and increased costs due to sorting and rejecting products.
In fact, if properly designed and implemented, a quality improvement program will result in cost reduction rather than increase. Standardizing the operation of an organizational and documented system can form the basis for a comprehensive quality management program. One of the steps towards improving management is the introduction of a quality management system that meets the requirements of the ISO 9000:2000 series. The management principles and quality criteria formulated in the standards, in fact, have absorbed the main experience of the international community in creating a competitive business. It is necessary to implement these standards in such a way that they work effectively in our enterprises. Quality Management System (QMS) – it is part of the overall management system of the company, which operates to ensure the stable quality of products and services.
A quality management system that complies with ISO 9001:2000 can serve as a basis for improving the management system and thus ensure the further and successful development of the enterprise.
ISO is short for International Organization for Standardization ( international organization(ISO) is an international agency with almost 100 member countries. Each country, regardless of its size, has one "equal" vote.
The paper considers methods for evaluating the effectiveness of the quality management system (QMS) processes.
QUALITY MANAGEMENT SYSTEM PROCESSES
One of the main tools for improving the activities of the organization in the field of quality, according to ISO standards 9000:2000 series is the measurement of performance operating system quality management (QMS). However, the methods for determining the effectiveness of the QMS are not regulated in the standards, so each enterprise is faced with the problem of choosing its own mechanism for determining the effectiveness of the QMS.
Efficiency is the degree to which the planned activities are implemented and the planned results are achieved.
Analysis (process) - activities undertaken to determine the suitability, adequacy, effectiveness of the process under consideration to achieve established goals. In other words, it is a generalized assessment of the process according to the established criteria.
The standards define the requirements for the organization to evaluate the processes of the QMS. The organization must:
Determine the processes needed for a quality management system and their application throughout the organization;
Determine the sequence and interaction of these processes;
Determine the criteria and methods necessary to ensure the effectiveness of both the implementation and management of these processes;
Ensure that the resources and information needed to implement and monitor these processes are available;
Monitor, measure and analyze these processes;
Take the actions necessary to achieve planned results and continuously improve these processes. [Appendix A]
Because we are talking about the calculation of the effectiveness of the system, then all aspects of the organization's activities should be disclosed and indicators of the system's performance should be identified for each aspect of the activity. In general, the assessment of the effectiveness of the QMS is the average value for all indicators of aspects of the organization's activities.
The methodology for evaluating the effectiveness of the QMS consists of the following stages:
Stage 1– development of assessment criteria And. Based on the definition, for each subsystem of the system we develop criteria based on the requirements of the standards for the QMS and set their planned values, according to which we will determine the effectiveness in the future.
Stage 2 - determination of indicators for each criterion. We calculate the relationship between actual and planned values for each criterion, which we will use to determine the effectiveness of the system.
Stage 3 - determining the significance of indicators. We determine the significance of the obtained indicators using the method of analysis of hierarchies T. Saaty. As a result of the calculations, weight coefficients for the indicators of subsystems were determined.
Stage 4 - determination of the effectiveness of each subsystem of the QMS.
Stage 5 – determination of the effectiveness of the quality management system.
Stage 6 – assessment of the sustainability of the quality management system. After determining the effectiveness of the QMS, we evaluate it on the Harrington significance scale, taking into account the following conditions presented in Table 1.
Table 1- Intensity scale of the criterion property of the QMS
| Name of gradation |
Numeric intervals |
System resiliency status |
System actions |
| Very high |
sustainable |
the system functions efficiently, but requires the development of preventive actions, if P ism = 1, then the system does not require the development of any actions. |
|
| sustainable |
the system functions effectively, but requires the development of minor corrective actions |
||
| sustainable |
the system functions effectively, but requires the development of corrective actions |
||
| not stable |
the system does not function effectively and requires the development of significant corrective actions |
||
| Very low |
not stable |
the system does not function effectively and requires the intervention of top management, if Р ism = 0, then the system requires development |
Stage 7 - making decisions on managing the quality management system. After determining the effectiveness of the QMS on the Harrington scale and based on the conclusions drawn, the representative of the QMS management, together with the owners of the processes, proceeds to develop corrective and / or preventive actions, improvement measures with subsequent monitoring and analysis of implementation. [Appendix B]
Thus, the information received on the effectiveness of the QMS is the basis for the analysis of the system by the management, is used for operational control of processes, revision of documentation and procedures, periodic review of policies and objectives, analysis and improvement of the QMS, informing staff and stakeholders.
To improve the efficiency and effectiveness of the enterprise as a whole and ensure the increase in the competitiveness of products, it is necessary to periodically evaluate the effectiveness of the quality management system. Efficiency must be calculated throughout the chain key functions and organization processes. An indispensable component of the analysis should be the comparison of indicator values for individual processes and functions, which should be used as a means of improvement. As a result of the assessment, the process model of the organization is refined, relationships between processes are established, areas for improvement are identified, and objective data on the state of the processes are collected. However, when declaring this principle, the standards do not offer a specific mechanism integrated assessment effectiveness. Therefore, issues related to the problem of an adequate and objective assessment, as well as the subsequent analysis of the effectiveness of the QMS, take on the form of a task, both theoretical and practical.
Among the various methods, the following can be distinguished:
calculation of QMS effectiveness based on scoring for specified parameters;
The model of index normalization of performance evaluation (MINOR);
· methodology for self-assessment of the effectiveness of the enterprise and the level of maturity of the QMS;
· integrated approaches to the self-assessment of the quality management of an industrial enterprise, including: audit, analysis of the QMS, self-assessment according to the criteria of ISO 9004, self-assessment according to the criteria of national quality awards, self-assessment according to the criteria of international models of excellence. [Appendix B]
Used in practice, quantitative approaches to assessing the effectiveness of the QMS are based mainly on the use of summary estimates of the growth of values with a limited set of indicators or criteria. Such indicators, as a rule, do not cover all aspects of the organization's activities and do not fully take into account the specific features of their formation and functioning.
When using the method of scoring the activities of an enterprise in the field of quality, a set of criteria for quantitative assessment is determined, which allows you to evaluate the activities of an enterprise in the field of quality as a whole. The criteria are ranked, each is assigned its own "weight" in points, while the number of points for each criterion is determined by pre-set estimated parameters. For the evaluation of the reporting period activities in the field of quality, the increase in the results of the assessment in relation to the base (initial period) is determined. Moreover, the assessment can be made both by the overall result and by individual criteria. The methodology allows assessing the activities of the enterprise in the field of quality and the dynamics of the effectiveness of the QMS. However, the use of this approach in almost all cases is possible only after choosing the estimated parameters and setting the criteria for their evaluation. However, in practice, not all criteria can be quantified, their limit values and the final limit of QMS effectiveness are not defined. In accordance with the MINOR, the entire set of key indicators within the framework of the QMS is converted from absolute values into relative ones, namely, into the chain growth rates of these indicators. This is the "dynamic" component of the model, i.e. when measuring the effectiveness of the QMS, the emphasis is on the magnitude of the increment this indicator, and not at its achieved absolute level. Despite positive points of this methodology, namely, a clear example of the dynamics of the main indicators of the enterprise's activities in the field of quality, there are some kind of problems. The definition of effectiveness in this case comes down to a comparison of some parameters, the choice of which is a difficult task for an enterprise due to the possibility of error in determining priorities for assessing QMS performance indicators.
As part of the methodology for self-assessment of the effectiveness of an enterprise and the level of maturity of the QMS, there is an assessment of the effectiveness of the QMS in points, summing up the most important aspects activities of the enterprise in the field of quality. Data for quantitative assessment of the effectiveness of the QMS of the organization is provided by the heads of the relevant departments for the existing or specially organized for this purpose statistical reporting. Depending on the specifics of the process and available data, it is necessary to develop a list of indicators that are most complete on this moment can characterize the state of the process. Most important indicators activities of the enterprise in the field of quality are presented in dynamics for several years. According to the dynamics of indicators, the effectiveness of the current QMS is evaluated. The main negative quality of this approach is the excessively large influence of parameters determined to a greater extent rather subjectively by the management of the enterprise.
All of the considered models are based on process approach» and determining the effectiveness of the QMS begins with the selection of a process and the collection of necessary information, the sources of which can be reports of divisions, acts, protocols, normative documentation, etc. Depending on the specifics of the process and the available data, it is necessary to develop a list of indicators that can most fully characterize the state of the process at the moment. Considering that the dynamics of process indicators is the main characteristic of these models, it is possible to draw up a generalized algorithm for determining the effectiveness of the considered methods [Appendix D].
However, such an assessment is practically not linked to the qualitative side of the organization's self-assessment and the development of an improvement strategy, therefore, in practice, self-assessment models are used according to the criteria of national quality awards. On the basis of quality premium models, a company management strategy is built, aimed at continuous improvement of the business. Moreover, the basis for any assessment are the criteria, which, in turn, are based on the assessment methodology. When the methodology is improved, then the evaluation criteria are also revised. The same process of growth of qualitative and quantitative improvement occurs with the performance criteria of the QMS.
It should be noted that when conducting a self-assessment of this type, the measurement of effectiveness extends not only to the QMS, but is also aimed at measuring the effectiveness of the organization as a whole.
The results of the analysis of the methods for assessing the effectiveness of the quality management system are presented in Table 2.
table 2 - Comparative evaluation of methodological approaches to assessing the effectiveness of the QMS
| Comparative indicators ( General requirements) |
Analyzed Methods |
|||
| Calculation |
Model |
Methodology |
Self-esteem |
|
| Goals of the organization and target orientation of the QMS for improvement |
||||
| Establishment of enterprise QMS processes, with performance evaluation |
||||
| Determination of quantification criteria and procedures for determining the effectiveness of the process and the entire QMS as a whole |
||||
| Dynamic component of performance measurement |
||||
| Obtaining a generalized indicator |
||||
| Measuring the performance of not only the QMS, but also measuring the performance of the organization as a whole |
||||
Note:
"+" - a tool is proposed that allows you to fulfill the corresponding requirement;
“–” – there is no tool that allows fulfilling the corresponding requirement.
Thus, in the self-assessment method according to the criteria of organizational excellence models, a systematic approach to measuring the effectiveness of the QMS is most fully implemented, taking into account its synergistic nature. In accordance with this approach, the requirements of IS ISO 9000 are no longer sufficient to assess the effectiveness of the QMS. If ISO 9000 MS considers the internal problems of the enterprise within the framework of the QMS, then the quality awards are aimed at the external problems of the organization, this is their difference.
Based on the presented analysis of approaches to assessing the effectiveness of the functioning of the QMS, it can be concluded that the approaches are not comprehensive, do not contain methodological support that fully meets the requirements of ISO 9000:2000. In addition, some of the areas selected as indicators are analysis procedures, and not indicators by which the effectiveness of the QMS can be assessed. Therefore, a fairly simple and at the same time reliable tool for assessing the effectiveness of the QMS is needed. This role can be performed by an approach that combines the provisions of both process and system approaches as a methodological basis.
The QMS increases the transparency of the enterprise in terms of its organizational structure, business processes and functions. When developing procedures, which are an algorithm of activities related to quality, are determined or refined and organizational structure(as commitments, powers, and relationships represented as a blueprint for how an enterprise performs its functions), and business processes and functions. It should be noted that this does not apply to financial transparency, as the QMS does not affect financial activity enterprises.
The manageability of the enterprise improves due to the fact that when designing the QMS, responsibility for the implementation of procedures is strictly distributed. Most procedures provide for the maintenance of quality records (reports) that form responsible persons after performing the specified actions. In the process of creating the QMS, provisions on subdivisions, job descriptions and work instructions are revised. It also improves the manageability of the enterprise.
The development of the enterprise is due to several factors. These include increasing the competence (mandatory training) of personnel, involving them in the process of creating a system, increasing production efficiency by eliminating unnecessary functions and reducing the proportion of low-quality products, concentrating efforts on the essential, as well as improving relations with consumers and suppliers.
The most obvious effective functioning of the QMS affect the competitiveness of the enterprise. The presence of a certificate significantly raises the authority of the enterprise, its trademark. This allows you to change pricing policy enterprises (obviously high-quality products should cost more). Having a certificate increases the likelihood of success when participating in competitions and tenders. In some cases, it is even a prerequisite for a competition or tender.
On the one hand, a study of the effectiveness and efficiency of management systems and their impact on the competitiveness of organizations showed that in modern conditions the functioning of such systems gives the organization real advantages over competitors based on the improvement of the organization of the enterprise. On the other hand, an important component of the development of enterprise management is the intensive development of integration processes both within the enterprise and with external environment, strengthening the cooperation of management subjects, their unification and interaction.
1. Methodology for assessing the effectiveness of the QMS of enterprises (organizations) of the military-industrial complex. M.: SDS "Military Register", 2006.
2. Reliability and efficiency in engineering: Handbook / Ed. V.S. Avduevsky and others. M.: Mashinostroyeniye, 1986.
3. STB ISO 9001-2009"Quality Management System. Requirements"
approved by the Decree of the State Standard of February 20, 2009 No. 8 (date of entry into force - June 1, 2009)
4. Stepanov A.V. The effectiveness of QMS processes // Methods of quality management. 2008. No. 2.
5. Tereshchenko N.V., Yashin N.S. // Methods of quality management. 2006. No. 4.
6. The functioning of the QMS and its effectiveness // All about quality. 2008. Issue. 53. 88 p.
7. Khokhlyavin S. Integration of management systems abroad is facilitated by national standards and practices // Standards and quality. 2007. - No. 7. - S. 62 -64.
8. Economics of organizations (enterprises): Textbook for universities / Ed. prof. V.Ya. Gorfinkel, prof. V.A. Shvandar. - M.: UNITI-DANA, 2003. - 608 p.
9. http://ru.wikipedia.org/wiki.
10. http://www.iskozh.com/articles/art3.html.
11. http://www.klubok.net.
APPS
APPENDIX B
APPENDIX B
Methods for analyzing the effectiveness of the QMS
APPENDIX D
Generalized algorithm for assessing the effectiveness of the QMS of an enterprise
Recently, more and more materials (articles, speeches, methods) have appeared on assessing the effectiveness of quality management systems, since the development and implementation of a quality management system (QMS) at enterprises, and the assessment of its effectiveness are the requirements of GOST R ISO 9001.
So, we will consider directly the assessment of the effectiveness of the QMS. The requirement that the QMS be effective appeared in the ISO 2000 standard. In accordance with this standard, “effectiveness is the degree to which planned activities and planned results are realized”. It follows that the effectiveness of the QMS can also be assessed by the degree to which an enterprise (organization) achieves its goals. However, the presence of any methodology in either GOST ISO 9001 or GOST RV 0015-02 is not required. Even the letter from Rosoboronzakaz addressed to the heads of organizations refers to the calculation of quantitative assessments of the effectiveness of the QMS, if it exists and if it is approved. Evaluation of the effectiveness of the QMS is a voluntary matter and enterprises or organizations themselves decide how to evaluate the effectiveness of the QMS. Each technique has the right to life, especially if it successfully works in a particular enterprise.
However, each enterprise notes the features in the formation of the methodology for assessing the QMS. For example, in the article the author says that it is more appropriate to evaluate the effectiveness QMS through process effectiveness, which is consistent with the requirements of the standard in clause 8.4.1. There are many methods based on the effectiveness of the QMS processes. You can, for example, refer to the methodology of the SDS “Military Register” or the methodology for evaluating the effectiveness of V.V. Goryachev. Of course, even when using the best methods, a large percentage of subjectivity is possible both in the choice of processes, their degree of importance, and in terms of evaluation criteria, weight coefficients, criteria for evaluating the effectiveness of the QMS itself. It says: “To distinguish a really existing QMS from a formal one, you need to evaluate the quality of its processes, and why their effectiveness.” And already "for the activity, considered as a process, it is possible to establish measurable indicators of quality." This assertion is not objectionable. Moreover, the evaluation of processes must be carried out based on the results of audits; feedback with the consumer; performance indicators of processes and conformity of products; the status of preventive and corrective actions; actions taken as a result of previous reviews; changes that could affect the quality management system; recommendations for improvement. And an assessment of the effectiveness of the QMS itself based on the use of the policy and objectives in the field of quality, the results of QMS audits, data analysis, corrective and preventive actions, as well as management analysis. One can also fully agree with the statements that " standard set there are no indicators of process quality” . This once again confirms the opinion that the QMS of various enterprises and various kinds activities are evaluated using the same methodology.
A. V. Glazunov in his article that when measuring the effectiveness of the QMS, an approach should be applied that takes into account the relevant aspects of the organization's activities and at the same time notes the advantages of using Performance Evaluation Index Normalization Models (MINOR).Performance indicators are a reflection of the actions implemented in the QMS, selected in the decision-making process. Any newly made decision and, accordingly, a change in the set of implemented actions is reflected in the dynamics of the corresponding performance indicators. That is why it is necessary to use measures of their dynamics, i.e., growth rates, as a sign of ordering indicators. In accordance with these requirements, to measure the effectiveness of the QMS and determine measures for its improvement, it is possible to use the model of index normalization of performance evaluation (MINOR). In accordance with the MINOR, the entire set key indicators within the framework of the QMS, it is converted from absolute values to relative ones, namely, to the chain growth rates of these indicators. This is the "dynamic" component of the model, i.e., when measuring the effectiveness of the QMS, the emphasis is on the magnitude of the increment of this indicator, and not on its absolute level achieved. Many scientific articles are associated with the dignity of this assessment technique, in addition, many enterprises successfully apply this technique in practice.
It is also worth noting that the assessment of the effectiveness of the QMS in terms of the interests of many stakeholders can be successfully carried out on the basis of a balanced scorecard (BSC). This point of view is expressed in their studies by various domestic and foreign economists,,. Among the shortcomings of the balanced scorecard for assessing the QMS, one can single out insufficient adaptation to the specifics of the activities of domestic industrial enterprises and their QMS, disregard for the interests of all stakeholders, poor compatibility with the process approach, etc. However, the dynamic effectiveness of the quality management system can be determined from the point of view of a comparative assessment of the benefits from participation in alternative investment projects and the methodology for evaluating investment projects.
There are plenty of methods for evaluating the effectiveness of the QMS and articles on this topic. But many of them have one drawback - they are somewhat difficult to implement and allow a wide field for interpreting the assessment of the effectiveness of the QMS. As noted earlier, there is no (and cannot exist in view of the personal characteristics of each system) a single methodology, organizations are encouraged to develop their own algorithms for assessing the effectiveness of the QMS, taking into account the types of activities, products and business processes. This is the problem of developing and implementing methods for evaluating the effectiveness of the QMS, taking into account the characteristics of a particular enterprise (organization).
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The GOST R ISO 9000-2015 standard classifies performance indicators as indicators that characterize the result of the QMS.
Basic data used in the calculation:
- indicators of the quality of manufactured products, which are contained in the reports of marriage, identified during the input control, during the acceptance finished products, with quality control in the production process;
- product test results;
- reports of the quality service on received claims, reclamations and complaints of customers about the manufactured products;
- summary results internal audits in a year;
- the results of the fulfillment of the objectives in the field of quality;
- information on indicators of efficiency and effectiveness of processes;
- architectural supervision data during the operation of products at the consumer (customer);
- supplier evaluation results.
The assessment of the effectiveness of the quality management system is proposed to be calculated as a weighted average of five particular performance criteria. The weight coefficients of partial criteria were formed by expert means and were taken equal to the values given in Table. 4.10.
Table 4 7 0
Weight coefficients of partial criteria for assessing quality
The value is defined as the weighted average of the indicators given in Table. 4.11.
Objects to be evaluated for /? P
Value R2 is defined as a weighted average of the indicators given in table. 4.12.
Table 4.12
Objects to be assessed forR2
Calculation formula
To calculate criteria R2 weight coefficients 5 are used, which are determined by an expert.
The basis for calculating the partial criterion R3 are the requirements of GOST R ISO 9001 and the number of nonconformities identified by the results of the audit (external or internal).
Where N- the number of requirements of GOST R ISO 9001 applicable to the activities of the enterprise; P- the number of identified non-conformities.
For the analyzed construction organization the number of GOST R ISO requirements applicable to its activities is N= 58. These requirements are contained in the internal regulatory documentation of the enterprise: in standards, instructions, methods. During the internal audit, it was revealed n = 11 inconsistencies with these requirements. Then R3= 0,81.
Private criterion R4 characterizes the degree of fulfillment of the established criteria for the effectiveness of processes. Quantitative criteria and performance indicators for the processes of the quality management system for their evaluation are established in documented quality management procedures. They will be subject to analysis and evaluation by the leaders of the relevant QMS processes with a certain frequency. When conducting an internal audit, the actual values of the QMS performance criteria are analyzed.
The effectiveness of the process P, is determined by the formulas
Here, with a decrease in a, f act, the effectiveness of the process increases, and with growth it decreases.
Here, with a decrease in a, -. f act, the effectiveness of the process decreases, and with growth it increases.
The organization has developed and approved the QMS processes given in Table. 4.13.
Table 4.13
Construction organization processes and their effectiveness
|
QMS process |
Estimated meaning |
Process weight b; |
|
Documentation management |
||
|
Interaction of the enterprise with the customer |
||
|
Design |
||
|
Quality assurance in the preparation and launch of products for production |
||
|
Construction, installation and drilling works |
||
|
Control vehicles used for work |
||
|
Measurement control during production |
||
|
QMS analysis by management |
||
|
Planning |
||
|
Information Support |
||
|
Personnel Management |
||
The indicator is determined R4 according to the following formula:
According to the calculation results R4= 0,96.
Particular criterion R 5 characterizes the quality of suppliers' products. It is calculated by the ratio of the amount of marriage (K marriage) to the total number of finished and delivered products (K delivered) according to the formula
In total, 8% of products from the total number of submitted products were rejected at the input control for the year.
The calculated values of partial criteria are summarized in Table. 4.14.
Table 4.14
Obtained particular criteria for the effectiveness of the QMS
QMS performance evaluation is a quantitative value Rqmk, defined as the weighted average of partial criteria R b R 2 , R 3 , R 4 , R 5 according to the formula
where pi is the weight coefficient of the i-th particular criterion given in Table. 4.10; Ri- value of the i-th criterion.
The calculated value of the QMS performance indicator is 0.93.
In accordance with the methodology for interpreting the results, the obtained assessment of the effectiveness of the QMS should be considered sufficient.
Experimentally, using the method of expert assessments, the values of effectiveness and weight coefficients of the QMS processes were determined. The assessment of the current QMS allows us to conclude that the effectiveness of the QMS of the enterprise is sufficient.
Implementation information support QMS processes will allow, according to the organization's specialists, to bring the effectiveness of the QMS to 1.
Remember concepts
Management, quality management, quality management system, quality policy, quality assurance, quality improvement, effectiveness, efficiency, Kaizen And kayryo, cycle PDCA.
Currently, many enterprises and organizations are implementing quality management systems according to ISO 9000 series standards. After the implementation of the system, there is an interest in evaluating its effectiveness and efficiency. But there is a difficulty in this task, due to the fact that the evaluation of effectiveness and efficiency can be considered in relation to a product or service, process or system as a whole, as well as for the entire company or structural unit, workplace or business process.
The GOST R ISO 9000 standard gives the following definitions:
“Productivity (clause 3.2.14) - the degree of implementation of the planned activities and achievement of the planned results.
Efficiency (p. 3.2.15) - the ratio between the result achieved and the resources used.
According to the requirements of GOST R ISO 9001 - 2008, the effectiveness of the QMS must be: ensured (clause 5.6.1), analyzed (clause 5.6.3), demonstrated (clause 8.4), constantly improved (clauses 4.1, 5.1) and constantly improved (clauses 5.3, 5.6.3, 6.1, 8.1, 8.4, 8.5.1). In addition, clause 4.2.4 requires the provision of evidence of performance. In essence, performance refers to the achievement of the organization's goals, i.e. it is "teleological" in nature and reflects the degree of implementation of some strategy, while efficiency rather refers to the assessment of the use of company resources in the course of implementing the strategy.
The main arguments in favor of the effectiveness and efficiency of the QMS are usually expressed as follows:
Cost reduction at all stages life cycle products;
Increasing revenues (increasing market share and corresponding sales volume, including through justified price increases);
Improving the manageability of companies by increasing the validity and efficiency of decisions.
Many experts believe that the effectiveness of the QMS should be defined, first of all, as economic efficiency by establishing a link between the implementation of the QMS and financial performance companies' activities. It is interesting to note that different specialists understand this problem in completely different ways and accordingly choose ways to solve it. Traditional "economists" are looking for ways to determine the economic efficiency of the QMS within the logic of traditional approaches that developed during the period when numerous standard methods for determining economic efficiency were in force in our country ( capital investments, new technology, automated control systems, NOT, standardization, etc.). According to this logic economic efficiency defined in two main ways:
2) economic efficiency = results / costs (or payback period).
Today, for most QMS specialists, it is obvious that the effectiveness and efficiency for different stakeholders are different, that it is always a matter of some balance of their interests and a possible compromise. What to consider as a result and effect is, first of all, a question of the company's strategy. In principle, any indicators can be used to evaluate the effectiveness and efficiency of management systems.
When evaluating the effectiveness of the QMS, it should be established:
The degree of implementation of the planned activities;
Degree of achievement of planned results in the field of quality.
The first assessment gives an idea of the degree of implementation of the QMS provisions of the organization and the degree of implementation of documents on planning and implementation of the product life cycle processes. The analysis of this assessment is made on the basis of determining the degree of achievement of the established outputs of the processes, as well as the degree of fulfillment of the requirements of the ISO 9001:2008 standard and the characteristics of the processes. The second assessment characterizes the degree of achievement of the set goals in the field of quality at various levels of the organization, including divisions.
Output values technological processes governed by standards specifications, product documentation, contract. The outputs of management business processes are regulated by quality plans for the organization of divisions, regulations on divisions. The characteristics of technological processes are regulated in technological documentation, quality plans, business management processes - in the quality plans of divisions, regulations on divisions.
As characteristics of processes, cost, technical indicators and timing indicators.
In order to improve the efficiency and effectiveness of the enterprise as a whole and ensure the increase in the competitiveness of products, it is necessary to periodically evaluate the effectiveness of the QMS.
As a result of the assessment, the process model of the organization is refined, relationships between processes are established, areas for improvement are identified, and objective data on the state of the processes are collected.
The GOST R ISO 9001:2008 standard aims to apply a "process approach" to improving the effectiveness of the QMS, therefore, determining the effectiveness of each of the processes, and then their overall assessment of the most common approaches.
Depending on the specifics of the process and the available data, it is necessary to develop a list of indicators that can most fully characterize the state of the process.
It is necessary that the selected process scorecard be:
a) complete enough to adequately evaluate the results of the processes and procedures;
b) its cost should be adequate to the value of information;
c) sufficient visual and simple information for analysis and comparison.
It is also necessary to resolve the issue of the target values of indicators, the sources of which are the policy and quality objectives, strategic plans enterprise and its divisions.
The calculation formula for determining the current value of the indicator should reflect the meaning of the concept of "performance". The resulting value must be compared with the normalized and target values of the process performance indicator and determine what actions should be taken in relation to this indicator.
If the current value of the performance indicator is less than its normalized value (Рm< Рн), то необходимо срочно разработать корректирующие и предупреждающие действия.
If the current value of the performance indicator is greater than the normalized value, but less than the target value (Рн? Рm? Рц), then it is necessary to develop measures to improve, as well as to increase the degree of implementation of the planned activities.
If the current value of the performance indicator is greater than its target value (Рm > Рц), then it is necessary to set new normalized and target values.
After all the indicators of this process have been considered, it is necessary to calculate the overall effectiveness of the process, taking into account the weight of its indicators and evaluate it.
If (Pm< Рн), то процесс не результативен. Требуется анализ со стороны руководства с целью выявления причин неэффективности процесса, а также разработка действий корректирующего, предупреждающего и улучшающего характера для немедленного налаживания критической ситуации.
If (Рн? Рm? Рц), then this is the expected level of performance. In general, the process is effective, it is necessary to take measures to prevent the occurrence of inconsistencies, as well as to increase the degree of implementation of improvements by analyzing current problems and making decisions to eliminate them.
If (Рm > Рц), then this high level process effectiveness. the set goals and objectives have been practically achieved, it is necessary to conduct research to develop measures aimed at improving the process.
It is necessary to consider all the processes of the organization and, taking into account the importance of each process, determine the effectiveness of the entire QMS (Rsmk, %) (form.1):
where, n is the number of organization processes,
Pi - the effectiveness of the i-th QMS process,%,
Ki - weight coefficient of the i-th QMS process.
The weight coefficients are determined expert method. Representatives of senior management act as experts, managers structural divisions, chief specialists. Experts evaluate the importance of the QMS processes on a ten-point scale with increasing importance and fill out a questionnaire processed according to the methods and rules of qualimetry.
The weight coefficient of the i-th process is determined by the following formula (2):
where Аi - the importance of the i-th process, measured by the expert method.
A feature of the process is its direct connection with all other processes of the enterprise. The following performance indicators were formulated for it:
Attracting qualified specialists;
Training;
Acquisition of new equipment and tools for industrial premises;
Condition of production equipment;
permanent staff;
Absence of industrial injuries;
Lack of sick staff.
Most often, when evaluating performance, a generalized indicator F (1) is used:
where fi , i=1, n - partial performance indicators of the QMS;
ai - coefficients of importance of particular indicators (weight coefficients).
A generalized indicator of the form (4) is used less frequently:
Combines generalized indicators the following:
The need to normalize the values of partial indicators fi , i.e.
ghosting them, firstly, to a single, often dimensionless, form (without this it is impossible to summarize and multiply the values of indicators), and secondly, to a single scale (range), for example, from 0 to 1;
The need to set the values of the coefficients of importance (weight coefficients) ai.
However, what does the obtained value of the generalized indicator say, for example, F = 0.75? Is it good or bad (or maybe satisfactory, excellent, very bad or very good)? To make such a conclusion, it is necessary to classify the states (determine groups of states) of the QMS performance (low, satisfactory, high, etc.) and the criteria (decision-making rules) for classifying the real state of the QMS performance to one group or another, for example:
F< 0,5 - низкая (неудовлетворительная);
F Є - satisfactory (average);
F Є - good;
F > 0.9 - high (excellent).
It is this approach that is implemented in 90% of the methods for assessing the effectiveness of the QMS and at first glance inspires complete confidence and at the same time captivates with its “solidity” due to the presence of a mathematical formula, the presence of a certain classification, and a lot of buzzwords.
Consider the types of criteria for a satisfactory state of the effectiveness of the QMS.
One of the main ones are the criteria for short-term goals of the 1st group:
Achievement of all goals;
Achievement of a certain number of goals (m) from the given ones (n) regardless of specific goals, and for the remaining (n - m) goals - at least 90%;
Achievement of a certain number of specific goals (m) from the given ones (n), and for the rest, including specific ones, - at least 90%;
There are also criteria for short-term goals of the 2nd group:
Achievement of all goals;
Achievement of a certain number of goals (m) from the given (n) regardless of specific goals;
Achievement of a certain number of specific goals (m) from the given ones (n);
For each goal, the criterion is set individually.
Criteria (annual) for long-term goals:
A certain percentage of achieving the goal - individually for each goal;
Any increment for each indicator with a set target value (target);
Achievement of a certain number of goals, and for others - at least 90% of the achievement of goals;
For each goal, the criterion is set individually.
Most recent criteria (final, i.e. for the last year):
For long-term goals: similar to the criteria for short-term goals of the 1st group.
Also, the assessment of the effectiveness and efficiency of the QMS can be carried out various methods, the most common methods are:
1. Comparison of planned Qi plan and achieved Qi rez values of outputs, characteristics, goals of QMS processes. If with an increase in the value of the indicator (for example, the organization's income) the QMS assessment increases, the following comparison scale Qi plan and Qi res can be adopted (Table 1.3.1).
Table 1.3.1. Comparison scale Qi res and Qi plan
If with an increase in the value of the indicator (for example, the proportion of defective products) the QMS assessment decreases, the inverse scale of the ratio of Qi res and Qi plan should be adopted in comparison with the scale in table 1.3.1.
Virtues this method are objectivity, ease of implementation. However, it is not suitable for indicators for which it is not clear which is preferable: Qi res > Qi plan or Qi res< Qi план. Этот метод не пригоден и для оценки показателей, которые трудно оценить количественно. Например, удовлетворенность потребителей, владельцев и т.п. Этих недостатков лишен второй метод.
2. Method of expert scoring.
Expert score in the general case, it is based on the choice of evaluation indicators, the assignment of certain point values to indicators; on the development of a methodology for calculating the value of each indicator; on compiling a scale of evaluation points for each indicator and calculating the final score specific type works.
Expert groups are created for scoring, and the organization of all work, including scoring, is entrusted to the working group.
It is proposed to evaluate the effectiveness of the QMS according to certain selected performance indicators of several levels.
The first level includes one indicator, namely, an indicator that characterizes the final assessment of the effectiveness and efficiency of the QMS.
The second level includes two indicators that form the final grade:
A generalized indicator characterizing the degree of implementation of the planned activities;
A generalized indicator that characterizes the degree of achievement of planned results.
The third level includes indicators that form generalized indicators, that is, indicators of the second level.
The fourth level includes indicators that form indicators of the third level (the number of indicators of the fourth level is determined by the organization itself).
Given the fact that the assessment of the effectiveness and efficiency of the QMS is not a one-time (one-time) action, but a continuous process carried out at regular intervals, the results of which should be used when considering the state of the improvement process in the organization, it is desirable that the estimated indicators do not change.
Evaluation of the effectiveness and efficiency of the QMS is carried out on the basis of an analysis of:
The first assessment of the effectiveness and efficiency of the QMS should be carried out only after a certain period has elapsed (preferably at least six months from the start of the functioning of the QMS). In the future, the assessment must be carried out after a period established by the management of the organization (once a quarter or half a year), but at least once a year.
Evaluation of the effectiveness and efficiency of the QMS can also be carried out in the process of its analysis by management. It is also closely related to the conduct and results of internal audit (inspection). When working out the procedures for conducting these two types of activities, their full interconnection should be ensured.
Based on the results of the work carried out, it will be necessary to develop a corrective action plan to eliminate the identified shortcomings and problems in the implementation of the planned activities and in achieving the planned results in the field of quality, which already relates to improvement activities.
Thus, studying the main provisions of the QMS, we can draw the following conclusions:
A QMS is a system created at an enterprise for the continuous formation of a policy and goals in the field of quality, as well as for the achievement of these goals in order to constantly improve the quality of products or services provided.
QMS consists of the following elements: organization, processes, documents and resources.
During the functioning of the QMS, the following principles must be observed:
1. The principle of priority of social and environmental effects;
2. The principle of an integrated approach;
3. The principle of ensuring the minimum impact of the incompleteness and unreliability of the information available;
4. The principle of comparability of results.
Efficiency refers to the degree of implementation of planned activities and the achievement of planned results, and efficiency refers to the ratio between the result achieved and the resources used.
Economic efficiency according to traditional approaches is determined in two main ways:
1) economic effect = results - costs;
2) economic efficiency = results/costs.
When evaluating the effectiveness of the QMS, it should be established:
1) the degree of implementation of the planned activities;
2) the degree of achievement of planned results in the field of quality.
Evaluation of the effectiveness and efficiency of the QMS can be done by various methods, the most common method of comparing the planned and achieved values of outputs, characteristics, goals of the QMS processes and the method of expert scoring.
Evaluation of the effectiveness and efficiency of the QMS is carried out on the basis of an analysis of:
The results of internal audits (checks) of the QMS, conducted in accordance with the requirements of MS ISO 9001:2001;
Data (records) obtained as a result of monitoring and measuring product characteristics in order to verify the achievement of product requirements;
Data (records) obtained as a result of monitoring and measuring processes in order to verify and / or confirm the ability of processes to achieve planned results;
Achieving the results set by the quality objectives in the relevant departments and at the appropriate levels;
Data received from feedback from consumers;
Data on the implementation of activities developed based on the results of the previous assessment of the effectiveness and efficiency of the QMS;
Preventive and corrective actions taken and implemented during the analyzed period.
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