On the eve of the International women's day specialists of our company held a field seminar in Grodno on the basis of the State Educational Institution "Grodno Regional Institute for the Development of Education" "Requirements of ISO 9001:2015 (STB ISO 9001-2015). Actions on risks and assessment of opportunities in the context of improving the organization's risk-based management. Internal auditor of the quality management system (MS ISO 19011:2018, GOST ISO 19011-2013)”, as well as “Practical aspects of risk management in accordance with the requirements of ISO 9001:2015”.
FROM 
The innovation management system helps organizations accumulate best ideas and constantly improve to keep up with the competition. A new ISO standard has recently been published in the innovation management series.
On February 24-25, a seminar was held at the information and consulting training center of our company on the topic: “ISO / IEC 27001:2013: Information Technology, security methods, management systems information security. Requirements. Internal audit of the information security management system”. The event was attended by specialists from several leading enterprises in the field of information and telecommunication technologies: Banking and Financial Teleset CJSC, Bevalex JV, MultiTech Engineering LLC, Company with limited liability Light Well Organization.
On February 20-21, in Mogilev, the specialists of our company held a combined two-day training seminar on the topic “Requirements of ISO 17025:2017 (GOST ISO/IEC 17025-2019), STB ISO/IEC 17025:2007. Internal auditor of the laboratory quality management system GOST ISO 19011-2013, ISO 19011:2018). The event was held in the conference hall of the Metropol Hotel.
On January 29-30, the specialists of our company held a training seminar in our training center: “Requirements of ISO 9001:2015 (STB ISO 9001-2015). Actions on risks and assessment of opportunities in the context of improving the organization's risk-based management. Internal auditor of the quality management system (MS ISO 19011:2018, GOST ISO 19011-2013)"
January 27-28 on the basis of our company and remotely, for representatives of medical device manufacturers: CJSC SOLARLS, IOOO Unomedical, UE Alkopak, PC LLC Respect-plus, LLC FOTEK (Yekaterinburg ) held a seminar on the topic: "Basic requirements of the international standard ISO 13485:2016. Internal auditor of the quality management system in accordance with the requirements of ISO 13485:2016, GOST ISO 19011-2013" Register" Anna Vasilievna Gorbar.
The processing of biological materials in laboratories or elsewhere is essential to many industries: from the diagnosis of diseases to the pharmaceutical and scientific research. But it is clear that there are dangers in doing so. Effective risk management of biohazardous materials means less chance of accidents, less impact on environment, more efficient use of time and other resources. A new International Management System Standard has recently been published.
On January 16-17, 2020, our company held a two-day seminar on the topic: “Product quality and safety management system based on hazard analysis and critical control points (HACCP System (STB 1470-2012)). Requirements. Internal auditor of the food safety management system (HACCP (STB 1470-2012), ISO 19011:2018, GOST ISO 19011:2013)”. The participants of the seminar were specialists from such enterprises as: JSC "Gomelkhleboprodukt" branch "Gomel Combine of Bakery Products", LLC "LibretikGroup", LLC "Fistaris".
Dear colleagues, partners and friends! The outgoing year 2019 has become an important stage in the life of our company. On the way to creating management systems already well-tested by us and mastering completely new standards for our market, it was full of fruitful work and a series of bright events, in which hundreds of specialists from enterprises from Belarus, Russia, Kazakhstan, Latvia, Moldova and other countries took part .
We do not stand still - the geography and professional orientation of our activities are constantly developing and expanding. And we are sincerely glad that through the development, improvement of safety and quality systems, our work benefits an increasing number of enterprises in strengthening the economic stability of the business and obtaining new competitive advantages.
On December 12-13, our company organized and conducted a two-day training seminar "Lean Production as a tool for continuous development efficient business» in the city of Gorki, Mogilev Region, for specialists from two enterprises: Molochny Gorki JSC and Gorki Food Plant IOOO.
The event took place on the basis of "Milk Hills". The leader of the training was a candidate of technical sciences, a practitioner in operational and strategic management Alexander Voronin.
(QMS, - ed.) is a set of measures and ongoing operations that are used in an organization to achieve required quality services or products - what is the result of the activities of this organization. The most important difference between a quality management system and disparate and random actions in the direction of improving product characteristics or preventing manufacturing defects is that the operation of the system is not random, but systematic and comprehensive, leading to predictable consequences in advance. According to the established practice, they are implemented on the basis of the international standard, which, moreover, has been adapted in our country as a national standard under the designation. The difference between the national copy and the original created by (International Organization for Standardization - ed.) comes down to the difficulties of translation, that is, it is almost absent. But, back to the definition. What does "required quality" mean? By itself, an object can be neither good nor bad, but it receives an assessment only from the point of view of a person. Quality is what is recognized as such by consumers. For this reason, the definition of a quality management system is usually added to meet the quality requirements that arise from external stakeholders: ordinary customers, partners, government agencies, other market players interested in the activities of an organization that implements ISO 9001.
The types of activities that the quality management system combines can be very different. Education plays an important role among them. We can say that it all starts with it, since before the implementation of the QMS, top management must study in detail the philosophy and practical aspects of the work of modern QMS, otherwise it will not be able to manage the process and give adequate orders to situations. Before, and especially during the functioning and implementation of the QMS, training is provided for middle management and ordinary employees of the company. They study both the ISO 9001 standard itself and the internal one, which was developed to implement innovations within the quality management system. In addition, direct performers learn to understand the needs of consumers of their labor. The ISO 9001 standard takes into account the close relationship between the processes in the enterprise and outside world, which, on the one hand, supplies raw materials for the organization, on the other hand, is the goal of its efforts. Depending on the chosen QMS implementation strategy, certain categories of employees study special software, the most modern instruments scientific analysis of certain issues related to quality in the enterprise. This is the principle position of the ISO 9001 standard. According to this normative document, decisions must be made on the basis of facts. If we adhere to this principle, the adoption of many decisions in the company should be preceded by a meticulous collection of information and a comprehensive analysis.
The creation, management and periodic updating of QMS documentation plays a huge role in the success of the implementation of a quality management system. This includes the development of a quality manual - a generalized document intended for familiarization of all employees, a kind of overview of the entire QMS, external documents on which any commercial structure is forced to rely: laws, the ISO 9001 standard itself, state standards. QMS documents also include internal quality standards, for example, specifications ( specifications, ed.). Below the quality manual in the hierarchy is a string of permanent documents, edited infrequently and updated constantly. also exist as separate documents. The development of documentation begins with marketing, revision of the goals of the organization, its resources and capabilities, structuring the activities of the enterprise in accordance with the process approach.
A scientific concept that proposes to consider any organization as a set of interrelated and interacting processes, the junctions of which are of paramount importance. process approach, according to the standard, at the enterprise, which allows to establish the sequence of QMS operations that require constant repetition. The cycle proposed in ISO 9001 allows not only maintaining quality at the level, but also improving it. Naturally, before “launching”, what specific processes consist of the activities of a company that has decided to create a QMS. This is usually very difficult. Being a universal document, ISO 9001 cannot offer a scheme of processes and their interactions for a particular enterprise. On the other hand, it gives a classification that contains the key to independent division into processes. The standard divides all activities into those related to organization management, resource management, life cycle processes, measurements, analysis and improvements. One of the most difficult aspects of working with the process approach is the following feature. Sometimes the conscientious application of this method leads to a revision of the entire organizational system of the enterprise. The processes may, of course, coincide with the structure of the departments of the organization, but a detailed analysis can also reveal unnecessary activities, inefficient administrative organization. If the management of an enterprise has difficulties in comprehending or implementing the provisions of ISO 9001, it has a whole series of guides that the International Organization for Standardization has released on various details of creating a QMS: ISO 10006, ISO10007, ISO 10012, ISO\TO 10013, ISO\ TO 10014, ISO 10015, ISO \ TU 16949, ISO 19011, ISO 10006 and a number of others. These documents relate to the internal audit of the QMS and certification, the implementation of the QMS and its adaptation to a particular industry, improvement of the system and other critical issues. In addition to these guidelines, the management of the enterprise still has the opportunity to resort to the help of numerous consulting organizations that have been professionally helping to implement the QMS for many years.
Let's talk separately about scientific tools for analyzing and changing the quality situation in an organization, as well as about electronic systems that can support the work of the QMS. Most of the former are based on statistics - their common name statistical methods quality control: plots, Ishikawa plots, scatter plots, tables QFD. Note that cyclic operations need not be based solely on PDCA. There are at least two alternatives: Juran's triads and Taguchi's methods. They can replace, in certain circumstances, or complement the PDCA model.
With regard to electronic systems that facilitate and organize the workflow of the QMS, it is worth mentioning here APQP(Advanced Product Quality Planning, - ed.) and ERP(Enterprise Resource Planning, - ed.), IDEF(Integrated definition, - ed.), FMEA(Failure Mode and Effects Analisis, - ed.).
The ISO 9001 standard does not establish a strict form in which the QMS workflow can be established, it can be embodied in the old fashioned way in paper form, but if an electronic document management system is used, then the use of the capabilities of IT technologies will be invaluable.
So, the creation of a QMS consists of the implementation of a process approach and PDCA, in accordance with the ISO 9001 standard, teaching management methods and approaches in management, marketing, developing an organization strategy with a plan, goals and accounting for resources, developing and implementing a transformation project organizational system enterprises, continuous professional development of employees, development of training plans for them, development of process design methods, development of documented procedures and enterprise standards. Anything else? Yes, as much as you want. The quality management system is a very flexible mechanism, capable of accepting new techniques and methods, and its potential can by no means be reduced only to the requirements of the ISO 9001 standard.
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Mikhail Yurievich Rybakov Business consultant, business coach, senior partner of Just Consulting, certified project management specialist (IPMA)
Alexander Leonidovich Shmailov Leading trainer-consultant on quality management, head of "Quality Management" at Just Consulting
Magazine "Management News", №1 for 2008
“The time challenge for businesses can be summed up as “faster and more cost-effective mastery of an ever-increasing variety of rapidly changing tasks”.
Alexander Leonidovich Shmailov
annotation
This article is devoted to the creation and implementation of a quality management system (QMS) in Russian company. After reading it, you:
- Find out what benefits your business will receive from the implementation of QMS
- Explore modern views QMS and you can choose the most suitable for you
- You will be able to understand how to create a QMS in your company and prepare it for international certification
The article is practical and is based on world practice and many years of experience of the authors in the field of quality in such companies as:
- Western: BEKO (factory in Russia), Daimler-Benz/Mercedes Benz Avtomobili, Trocal, KBE, TUV EC, Volvo Truck Corporation Russia, Kuhne+Nagel LLC Russia, etc.
- Russian: BeeLine, Business Process LLC, Corbina Telecom, Moscow Business School, Sawatzky, Yukos NK, etc.
The entire article will be based on a single cross-cutting example. As our hero, we took the conditional company "Etalon". This is a multi-brand car dealer-center for the sale, repair and maintenance of cars of European brands. This example is good because:
- firstly, many of us regularly use the services of stations Maintenance cars (STOA)
- secondly, this example can illustrate the implementation of QMS in companies engaged in sales, production and provision of services.
History of the company. Problems
Etalon was founded in 2001. At that time, she was engaged in the maintenance of Volkswagen cars. Over time, they also began to sell and serve a number of Japanese and Korean brands. Today, Etalon is one of the leaders in the regional market. However, in recent times competition is becoming more and more fierce and therefore the company began to pay more serious attention to those points that had not previously reached the hands:
- Service station personnel do not comply with time standards and company standards
- The directorate believes that the performance of direct work force(mechanics, electricians, diagnosticians) could be much higher
- Customers are not entirely satisfied with the quality and speed of service
- Rare customers re-apply for services: go to competitors
And consequently:
- The company is losing market share
- Owners and investors are not satisfied with the return on invested capital.
Of course, these problems were not new to management. And, of course, they tried to solve them:
- Installed video surveillance of the work of mechanics, locksmiths and electricians
- Raised or lowered the level of the bonus, linking it to performance
- Trained receptionists in customer service
- And much more
However, all this gave only a temporary improvement. And then one day the owner of the company heard that there is such a science - quality management, and decided to implement it in his company.
What is quality management and what does it provide
What are the business benefits?
Advantages that you can get are very diverse:
- Reducing production costs and increasing profits
- Increasing the capitalization and investment attractiveness of the company
- Increasing the manageability and transparency of the company for management
- Growth of motivation and loyalty of employees, improvement of the atmosphere in the team
- Increasing customer satisfaction
- Developing the image and increasing the competitiveness of the company
- Opportunity to enter foreign markets and cooperate with major Russian companies
- Continuous improvement of the company's performance
By what means is this achieved?
Simply put, quality is about how to build your business "wisely". Distinguish:
Quality management is the same area of management as production, finance, personnel and others. But at the same time, it is more complex, influencing all aspects of the company's work, and therefore under the jurisdiction of its top management.
And all the successful companies in the world (from such giants as Daimler-Benz to small companies) in various business areas are dealing with these issues.
What are quality management systems?
There was a time when every leading company created a QMS on its own. However, in order to “not reinvent the wheel”, various best practices have been created based on the practices of the most successful global companies quality standards, for example:
- ISO 9001:2000
Talks about how to build an efficient, long-term successful company, regardless of its business area. It is also used to evaluate partners: how risky it is to work with them.
This standard is the base for all QMS created in the world, so we will take it as a basis for further presentation. Other standards specify and detail the requirements of ISO 9001:2000 for specific countries and industries.
- ISO QS 9000
Standard for evaluating suppliers and contractors in the automotive industry. Adopted by the "big three" American car companies: Ford, General Motors, Chrysler. - VDA 6.1/6.2
European standard similar to ISO QS 9000. Adopted by German companies such as BMW, Volkswagen, Mercedes, Siemens. - ISO TS 16949
An international standard that has grown from the above.
But that's not all. If you have implemented a QMS, then you have reached a certain basic level for the industry. But the competition is growing, and if you want to develop further, your guide can be programs for further improvement, for example:
- Statistical Process Control (SPC)
A set of techniques for product quality control at all stages of the life cycle. - Quality Cost Management
Cost reduction from low quality (marriage) due to its prevention. - Toyota production system - TPS and Lean(Lean production)
Toyota production system. It is one of the most successful quality management systems in the world. - Advanced preventive maintenance (TPM) techniques
A system of Japanese methods for evaluating and improving the overall efficiency of manufacturing equipment. - Six Sigma
A system originally developed by Motorola. It is based on a project approach when implementing improvements and a clear organizational structure.
Basic principles of quality management
In the work on quality, one can distinguish 3 levels:
1. Ideology
2. Psychology
3. Tools
"What does this mean? - you ask. - What about the ideology? In our country, this was more than enough! Look at the results!
That's right, but the whole point is that an employee of the company can be given the best tools, machines and equipment, but if he won't want work efficiently, all your efforts will be a waste of money and time.
Ideology needed to shape public opinion. For example, in Japan, the principle “It is a shame for a good person to work badly” is promoted. In the US Quality is often compared to religion. A person cannot be forced to believe in God. Also with quality. It is impossible to force - but you can convince, create the appropriate mood within the framework of a separate project, company or the whole society.
Understanding psychology an employee is needed in order to be able to convey the basic principles of quality to employees.
BUT tools help to put into practice the principles of quality.
Quality as a discipline was largely created by the efforts of individuals. They are often referred to as "Quality Gurus". It was they who laid the ideological foundation of quality as a management discipline, developed tools that are actively used all over the world.
Edward Deming is rightfully considered one of the founders of the world science of quality. In the 1940s In the 20th century, he worked as a professor of statistics at New York University. At that time, for the first time, he had the idea that statistical methods could be applied to quality management. He offered his work to many American companies, however, at that time his ideas were not accepted in the US business community. He tried to find understanding in a number of countries of the world, including the Soviet Union. He almost stayed in our country, but the country's leadership demanded that he publicly declare that Soviet industry- the highest quality in the world. Having familiarized himself with the state of affairs at several factories, he could not take such a step, which means he was forced to continue his search for the country where his ideas would be accepted. Japan is such a country.
After the Second World War, Japan was in a very difficult economic situation, and the goods that its industry produced were completely uncompetitive due to very low quality. For six years, Dr. Deming lectured and advised Japanese business leaders and government officials. As a result, the Japanese were able to put into practice new management principles and become world leaders in the quality of their products.
Much later, in the early 80s, many years after the beginning of the "Japanese industrial revolution”, in the book “Out of the Crisis”, Deming formulated his famous "14 principles of quality", which reflect his many years of successful experience in quality in largest companies around the world.
The essence of Deming's approach is that the causes of low efficiency and poor quality are most often embedded in the system, not in the workers. Therefore, to improve production results, managers must adjust the system itself. Deming paid particular attention to:
- need collection of statistical information about deviations from standards
- reduction of deviations in the processes and products of the company
- at the expense search, analysis and elimination of the causes of deviations.
So let's consider "The 14 Principles of Edward Deming" which to this day are the basis for quality management worldwide.
1. Striving for improvement
“Make it so that the desire to improve the product or service becomes constant; your final goal“become competitive, stay in business and provide jobs.”
Rice. Increasing quality in Japan and the USA
The Japanese are very fond of telling how they overtook America in quality. And do you know how they explain their success?
In the US, quality is improved on a case-by-case basis when there is some kind of technological or managerial breakthrough. In Japan, one of the components of any work is its continuous improvement (Kaizen). How this happens, we will look at just below (the PDCA cycle). In the meantime, I suggest you think about the question: how does quality change over time in Russia? Consider the quality dynamics of many brands that have appeared on the consumer market in recent years…
Iterative improvement (PDCA cycle)
One of the main principles in the development of quality is the principle of continuous improvement. It finds practical implementation in the implementation of the famous PDCA cycle (from English words: plan- to plan, do- do, check- check, act- act), developed by Edward Deming.
This principle symbolizes the infinity of the process of improvement. Imagine that you are sailing on a boat towards a certain destination. The boat will be periodically carried away by the current, deployed by the wind. To sail to the intended goal, you will have to regularly adjust your course using the feedback principle. Note that goals can change… However, in business people often think that once they find the right solution, they can use it forever.
Rice. PDCA cycle
Often the PDCA cycle is depicted as a person pushing the wheel of continuous development up an incline. The circle symbolizes the continuous nature of improvement. This symbol is very popular in Japan, as is the technique itself. For example, the PDCA cycle is often a topic of discussion in Quality Circles.
2. New philosophy
“We are living in a new economic era. Leaders must rise to the challenge of this era, must realize their responsibility and become leaders in order to bring about change.”
If you want to run your company using the old "I'm the boss, you're the fool!" principle, it's best to stop talking about quality right away. The experience of most companies that have successfully implemented a quality management system suggests that everything starts with a belief in the quality of the top management of the company. And often at first you have to overcome the wall of misunderstanding and resistance on the part of the bulk of employees and middle-level managers. Quality is “doomed to success” only if top managers accept it as one of the main priorities in the development of the company, regularly proclaim its important role, and most importantly, they themselves adhere to the principles of quality in their daily work, convincing employees to follow the new course by their example.
3. Termination of mass checks
“Overcome dependency on quality control. Quality cannot be ensured through mass inspections, it must be the result of a sustainable product manufacturing process.
Initially, quality as a management discipline arose with the introduction of assembly line production at the beginning of the 20th century. Until then, the craftsman, who produced his products in small batches, could himself control the production process from beginning to end. And the worker standing on the assembly line became separated from the results of his work, that is, those “10 nuts” that he tightened every day from morning to evening were very far from the shiny beautiful cars that left the assembly line after assembly and finishing.
Then, for the first time, the idea of creating a QCD (technical control departments) arose, that is, special divisions arose, whose main task quality control of manufactured products. The main problem of output control is that even if some scrap finished products found, fixing it can be very costly for the company, and often there are "hidden defects" that are discovered only when the product reaches the end user.
Also a disadvantage of mass control are psychological problems arising in production in the presence of a large number of controllers. Who likes to work when the vigilant eye of the overseer is constantly watching you?
The opposite of total control is development of business process quality and technological process so that the emergence of marriage will be impossible in principle. Also, one of the goals is to process reproducibility. For example, one car can be produced in a garage, but in order to make a thousand of the same, and even with workers of different skill levels, quality management is needed.
4. Caution with cheap purchases
“End the practice of buying based on finding the lowest price, instead, minimize total costs. Try to have one supplier for each of the components, work with him on the basis of a long-term trusting relationship.
Any company depends on the resources that it acquires on foreign market. Often management forces purchasing managers to focus on minimum prices. However, when choosing suppliers, it is important to pay attention not only to the price of purchased products, but also to total cost possessions this resource during the entire period of its operation, which includes the cost of repairs, and spare parts, and losses from downtime of resources purchased cheaply. Often a simple economic calculation shows that it is better to buy more expensive, but high-quality products. You can calculate what is more profitable: invite a team of professionals or a team of guest workers to build your cottage, who are sober only at the time of the conclusion of the contract, and took the trowel for the first time in their hands a month ago. As the saying goes, "I'm not rich enough to buy cheap things"...
5. Continuous improvement of systems
“It is necessary to constantly look for the causes of defects in order to improve in the long term all production and service systems, as well as any other activity related to the enterprise.”
This principle tells us how important it is to analyze the causes of problems that arise during the work of the company. “There are no defeats - there are only Feedback", say the wise. Our mistakes and miscalculations are an invaluable experience that will make it easier for us to succeed in the future. Only a detailed consideration of the causes that led to a particular problem can eliminate it in the future. It is extremely important from the very first steps of project development to cultivate in employees the principle of a detailed analysis of emerging difficulties in order to take real steps to eliminate them and prevent them in the future.
There are a number of tools that allow you to analyze the causes of existing or potential problems.
6. Personnel training system
"Create an on-the-job training system."
Have you noticed that often a young specialist who comes to work after studying at a university has no idea what needs to be done, even if he works in his specialty (which is a rarity these days)? How to grow professionals who will successfully cope with the tasks assigned to them, and will also become the backbone of the company in the future?
World experience shows that a mentoring system can help in solving this problem, when experienced employees train young newcomers. This approach gives a “triple effect”: you educate young people, increase the loyalty of experienced specialists, unite the team, and lay the foundations for respectful relationships between colleagues.
7. Effective leadership
"It is necessary to apply modern methods guidelines designed to help workers do their job better.”
A well-known principle says that in order to get a different result, it is necessary to make some changes in the system. That is, if you do not change anything, then the result will be “as always”. Are you satisfied with the work of your employees? Not? Then who is responsible for making changes happen in your company?
In the new conditions, when more and more results are expected from the employee, as well as a responsible, creative approach to work, the leader is no longer the taskmaster over the “negligent worker”, which he often used to be. Modern approach to management implies a partnership of employees and managers, in which the manager is assigned the role of a mentor, a “senior comrade”, who can show the employee the way to his professional growth.
8. Eliminate the climate of fear
“It is necessary to promote mutual communication and use other means to eliminate fear among workers. Then people will be able to work effectively in the interests of the company.”
What are employees afraid of? It is worth starting a conversation about this with the fact that in any company with more than 100 employees, the interests of business are largely replaced by the interests of building a career within the company. This means that all actions taken by the employee will be aimed at increasing their merits in the eyes of the authorities and hiding all the mistakes.
What does this lead to? People are starting to get scared. To be afraid to talk about the mistake made, once again turn to the management with a proposal for improvement: “How will they look at me? Will they not be punished? Will they make me responsible for the implementation of my proposal? What if I can't do it?" As a result, a person takes only the most “safe” jobs, seeks to shift responsibility to colleagues and managers. And what kind of creative approach to work can one speak in such a situation in a team?
Another negative consequence of the fear of punishment in production, the division of the company into "bosses" and "ordinary workers" is the emergence of mutual responsibility among ordinary employees. negative consequences- lots of. This is both theft and mutual concealment of inaction and mistakes.
What is the reason for this situation? The main reason for confrontation between employees and management is usually fear. After all, it often happens that when problems are discovered (for example, the occurrence of a marriage), the management is engaged in “search for the extreme”, “so that it is disrespectful”. And the problem often lies in the problems of labor organization, the shortcomings of the system.
A number of successful companies introduced the following principle: if an employee himself admitted his guilt in making a mistake, he is not only not punished, but also rewarded if he came up with a real way to prevent this mistake in the future. After all, now this employee has gained valuable experience! Of course, this does not apply to those who make mistakes every day. However, as practice shows, most employees really strive to do their job as best as possible. Don't bother them!
9. Eliminate barriers
"It is necessary to eliminate barriers between individual areas of the company's activities, divisions."
You have noticed that sometimes in companies you can hear such conversations.
Accounting: “These salesmen are bums! Not only do they come to the office only in the evening, but also the documents are constantly delayed!”
Sellers: “This bookkeeping is a complete swamp! Not only do they sit all day, wipe their pants, they also constantly make mistakes in the calculations, and you won’t get documents from them!”
If you hear such conversations in your project, it means that you have opposition of divisions. Why does it occur?
The fact is that most of the company's employees are engaged in their own narrow business, they do not notice the importance of what other departments are doing, the problems that exist in their work. Which means what other departments are doing starts to seem unimportant. As a result, conflicts and mutual accusations arise.
What to do in such a situation? As a rule, this situation is resolved through a series of procedures aimed at resolving conflicts and establishing constructive interaction between departments. Moreover, to hold such events, people are needed who will not be “their own” for any of the parties, and often a team of invited consultants plays this role.
10. Rejection of slogans
“It is necessary to eliminate slogans, appeals and warnings. They only cause opposition, because in most cases low quality caused by the system, not by the behavior of a particular worker.
“You must work with high quality!”, “Five-year plan - in three years!” - we have already heard all this somewhere, haven't we? When you hear such a fiery call, what desire arises inside? To work qualitatively, or to do something else in relation to the one who repeats this slogan every day?
Does this mean that propaganda is not needed at all? How to be? How to convey the necessary ideas to employees? Moreover, above the author spoke about the "ideology of quality". Is there a contradiction here?
It certainly exists, but there are ways to resolve it. First, modern methods of creating public opinion (PR) are much more subtle than just saying slogans. Secondly, there are other ways to convey ideas to the masses, for example, the work of Quality Circles, which, in our experience, work very well in Russia (of course, if they are properly organized).
11. Refusal of arbitrarily established norms (quotas) in production. Change of leadership
a) “Abandon quantitative quotas for workers”;
b) "Abandon the quantitative goals of the administration."
As the practice of implementing quality management systems shows, there is always a contradiction in companies: to work efficiently or work well. In general, our whole life is woven from contradictions. For example:
Car: prestigious or cheap?
Travel by train or fly by plane?
Employee: smart or accommodating?
One of the tasks of the project manager is to resolve such contradictions at the earliest stage of planning. Moreover, the situation is often complicated by the fact that priority quality in work contradicts those quantitative production standards, which are set for workers. They would be happy to work well, but at a certain level of workload it becomes physically impossible.
How to be? Find compromises between quality and quantity, and not hit one of the extremes.
12. Taking pride in your work
“Everything that calls into question the ability of every rank-and-file employee and every manager to take pride in their work must be eliminated.”
Have you noticed how different are those who go to work “just to earn money” and those who are proud of their professionalism, their team, their company? And, nevertheless, how many obstacles managers sometimes create on the way of employees to a sense of pride in their own company! To the extent that employees of the recently spun off subsidiaries of a very large Russian company who work side by side with it every day are forbidden to wear its symbols! It's hard to see the bitterness in people's eyes when they talk about it! People just give up on being treated like this...
But sometimes it is necessary to take very simple actions to maintain self-respect in an employee, pride in his profession. Such methods as honor boards and award certificates are still relevant today. And how quite adult serious people rejoice when they receive a postcard signed by the head for a professional holiday!
13. Encourage learning
"It is necessary to create a comprehensive training program and an environment in which self-improvement becomes the need of every employee."
Are your employees frequently trained? Not? And you want them to keep up with the changes that are taking place in our lives?
They say about Japanese companies that everyone teaches everyone there, and this is one of the reasons for the rapid growth of the Japanese economy. In our country today there is such a situation that up to 70% of the population work not in their basic profession. Engineers are in charge, psychics treat, and everyone who could not find a place in other areas goes to salespeople. And what do you expect from such employees? It is surprising to observe what hopes the head of such a newly minted sales department places on his "eagles", of which one wanted to become a doctor, but quit, the other is looking for a job after a culinary college, and the third generally just came from the army. Of course, these can be quite worthy people, however, it never occurs to anyone to put a peasant in a pilot's seat and send him across the Atlantic!
Create such conditions in which it will be prestigious for the employees of your company to study. For example, you can link career with the passage of certain trainings, or obtaining a "second higher".
14. Transformations are everyone's business
"Get every worker involved in the change program."
The people say: "One man is not a warrior." Well, what will you achieve in the field of quality if your employees in the smoking room will giggle at you, discussing “another whim of the boss”?
One of the first tasks of the project manager is to involve all employees in the work on quality improvement. And make sure that people participate in it voluntarily and with enthusiasm.
It should be noted here that although Deming's principles have proved their effectiveness in Japan and other countries of the world, they have been developed for a long time, and the Japanese mentality is significantly different from the Russian one.
That is, when borrowing any advanced experience, you should creatively process it under the conditions of your reality. What principles will you develop for your company, based on the best world experience?
Creation of the QMS
So, how is QMS created? As with everything, there is at least two ways:
- do it yourself;
- order on the side.
Americans call it "make or buy". Both have advantages: in the first case, you will learn a lot, fill your bumps, and get the most adapted system, but it will take you a lot of time. In the second - spend more money, but save time and get a quick professional-level result.
Most people choose the second option. We will consider it using the example of the Etalon company.
There are a few milestones:
- Training
- Analysis of the state "as is"
- Quality management training for managers and staff
- Documentation development
- Formation of QMS documentation
- Implementation
- Internal audit
- Training of internal auditors
- Holding internal audits
- Quality management report to top management
- QMS certification
- Re-audits, continuous improvements, recertifications.
Training
Analysis of the state "as is"
To begin with, the consulting company conducts preliminary rough assessment of the client in order to determine the contours of the future project. Evaluated:
- Industry of the company and directions of its business
- Organizational structure, leadership structure, number of staff
- Does the client need certification, if so, what kind, why and in what time frame
- And other options.
Rice. Organizational structure of STOA
It is worth mentioning here that certification varies.. Companies can be classified in different ways. For example:
- "Sale of the certificate" + QMS as a bonus. Wishful thinking.
- Assistance in creating the organizational maturity of the company (speed, accuracy, quality of fulfillment of customer orders) + certificate as its confirmation.
The first option is more widely distributed on the market, and the second, alas, often comes down to the first in the course of implementation. A truly professional consultant can do both options, but initially focuses on the second. Its benefits have been described above in the "What are the business benefits?" section. It is about him that we will talk further.
Certification also happens:
- Western(TUV, Lloyd register, BVQI, DNV, SGS, etc.)
- Russian(GOST-R, VNIINMASH, Russian register, etc.)
Western certification bodies are good because they have many years of experience and reputation, they transfer successful experience from other companies, but their services are very expensive.
At the same time, Russian ones are cheap, but the emphasis during implementation is more on the administrative resource, coercion.
Based on a preliminary assessment consultant makes an offer to the client, where he describes the goals of the project, its stages, cost. As a rule, the client arranges a competition (explicitly or not) among consultants. A contract is concluded with the winner, in which technical task(TOR) and the project plan are included in the annexes. This is very important, because allows "on the shore" to agree on mutual expectations and requirements, the scope of work. Otherwise, the project tends to "grow", which leads to dissatisfaction on both sides.
It is also worth mentioning that success or failure of the project largely depends on the client. So, often he strives to carry out the most expensive stages on his own, and does not do it, or does it poorly. And sometimes the project is greatly delayed due to the lack of key persons of the client (business trips, etc.), delays in providing information.
Likewise, in the preliminary stages "grinding" the consultant and the client. After all, mutual trust is important for success: a consultant often learns a lot of confidential information about a company. No wonder the preservation of trade secrets is an important point of any consulting contract.
For the success of the creation and operation of the QMS, the support of the key persons of the company, incl. its top management. Therefore, it is useful to carry out the so-called kick-off training, which describes the key benefits of creating a system, the mechanisms of its work and the stages of its creation.
- define weak spots and risks in the client's business (non-compliance with the standard)
- identify improvement potentials that can be implemented, preferably at minimal cost. Sometimes they are also called "low-hanging fruits."
A phased survey of the company's personnel is carried out, starting from top management to performers.
Further implementation largely depends on the literacy of this stage. If the consultant is competent, then already at this stage vision of "how it should be", and not only for him, but also for the client.
This stage ends formation of a QMS implementation project in company.
An example is provided at the beginning of this section. You can supplement it with a network diagram, a Gantt chart and a responsibility matrix.
Documentation development
Identification of the main processes of the Company
At the next stage, it is necessary to implement the concept that has developed after analyzing the current state of the company. And, first of all, it is necessary to develop a “company concept”, and not so much “as is”, but “as it should be”, taking into account the requirements of the ISO 9001:2000 standard. In quality management, this scheme is called process landscape: it contains the names of the processes taking place in the company and, possibly, the links between them.
Processes are divided into three groups:
- Company management processes
- Core processes (which add value to the customer and bring profit to the company)
- Supporting (auxiliary) processes.
However, we follow the approach proposed by the Austrian consultant Karl Wagner (ProCon), which also highlights:
- Measurement, analysis and improvement processes.
This allows you to ensure that the created QMS will actually perform its functions: to contribute to the prosperity of the business. If these processes do not exist, the QMS is just a declaration.
Rice. The relationship of processes in the company.
Displayed first basic processes as the most important for the company. We follow the entire path from receiving a customer's order to issuing a finished product or service. For example:
- Finding and attracting clients
- Conclusion of contracts
- Fulfillment of orders
- Development of new products (R&D).
Note that the division of processes into groups is very conditional and controversial, and primarily depends on the scope of business and the goals of the company. For example, for a bank, financial management is the main process.
- Selection and evaluation of suppliers
- Work with personnel
- Life support of the office, technical processes
- Safety.
For core and supporting processes to function successfully, they need to be managed. For this there are governance processes. For example:
- Strategic Management
- Tactical control
- Operational management.
You can manage in different ways. It is possible, based on the intuition of leaders, or it is possible - on facts, preferably expressed in digital form. For this, it is necessary to produce measurements, then analyze received information. And based on the analysis improve operation of the entire company or individual processes. Let's say, in our example, the head of the workshop set the price of an hour for the paint shop to be 40 euros. Based on what: competitor analysis, customer surveys? Such a leader takes a very big risk if, for example, the cost of an hour is 37 euros: pretty soon his business will collapse, and he may not even suspect it, because. it does not have a system for collecting and analyzing evidence.
Detailed description and development of processes
- Name
- Owner (responsible)
- Process boundaries (start and end)
- Inputs and outputs (starting with outputs)
- Process execution logic
There are many ways to describe processes, from the simplest to the most complex, such as IDEF0 and ARIS. However, we recommend using the simplest flowcharts: they are less scientific, and everyone can easily understand them.
Rice. Description of the order processing process in the STOA "Etalon"
In the course of the description, the processes are repeatedly adjusted and improved. Their landscape may also change. It is convenient to single out 4 working groups from among the company's employees, each of which describes the processes of one of the groups indicated above.
Definition of QMS management procedures
In order for processes to be effectively executed in accordance with the requirements of ISO 9001:2000, it is necessary to develop six mandatory QMS management procedures:
- Document management
- records management
- Nonconformity Management
- Management of internal audits
- Corrective actions
- Preventive measures
To documentation QMS was convenient to use, it is necessary to form some of its structure and document templates.
Entries needed to record how a particular job was done. Remember the sheet on which the cleaner marks the time of cleaning the restroom of a restaurant - this is an example of records.
Rice. Recording example. "Form of acceptance of a car for repair"
Nonconformity management is dealing with customer complaints, both external and internal.
Internal audits are necessary in order to assess what does not lend itself to the normal system of measurement. For example, the quality of documentation. First of all, the performers are asked about the implementation of the given regulations.
If during the audit non-compliance with the requirements of the standard was identified, it is necessary to take corrective measures that correct them.
And so that in the future inconsistencies do not arise in principle, preventive (preventive) measures are taken.
Formation of QMS documentation
Of course, the QMS must be documented. Documentation is built in the form of a pyramid:
 |
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- At the top level— the company's quality policy and objectives, which are detailed in the Quality Management Manual. This documentation is provided in general view and is of an "advertising" nature. It is provided to clients, suppliers, partners. However, it contains links to the next level, which contains the know-how of the company, which means that access to it should be limited.
Quality policy
- Customer orientation
We focus on the needs of our customers and work with them in a friendly and considerate manner in order to achieve permanent partnerships reliably and in the long term.- economy
We are committed to acting from an economic point of view. We find out the processes of our company from the point of view of their economic sense and efficiency. For our customers, we maintain up-to-date technologies and fundamental knowledge and guarantee this. We strive for the subsequent coverage of costs and the competitive cost of our products.- Service quality
Our activities are defined within processes that should ensure the highest quality of our services. Responsibility and competence are clearly defined in order to ensure clear information flows, regulations for the regulation of interfaces.
Prevention or rapid resolution of nonconformities is part of our process-oriented QMS.
- On average— descriptions of processes and procedures. These are documents that regulate the activities of the company: how to analyze the market, how to work with suppliers, create new products etc.
The above is an example of a process description. - On the bottom- work instructions job descriptions, drawings, operational instructions, forms of documents, etc.
Implementation
Once the QMS is established, it must be implemented. For this you need:
- Share Responsibility for the implementation of established processes between managers and employees.
- To train. It is recommended to train managers first, who then train their employees.
Internal audit
Now we need to check how much what we planned corresponds to what we actually have. The main goal is to improve the created system.
Training of internal auditors
First of all, it is important to determine who will be the internal auditors. A good auditor can be a person who is configured not for authoritarian control, but for the search for opportunities to improve the system.
Then spend education both the audit procedures and the necessary skills, such as asking effective questions, listening, identifying the causes of problems, suggesting improvements, separating problems from specific people, etc.
Then spend exam where the future auditor demonstrates his skills.
Conducting internal audits
The audit is carried out approximately one week after the implementation is completed. When it is carried out, the following options are possible:
- Everything is described and works. Everything is good here.
- If it is described, but does not work, then they decide whether a description is needed.
- If it is not described, but it works, then they evaluate whether a description is needed for the repeatability of processes, or whether it is enough to create a “checklist” or conduct a simple briefing under the signature.
- Not described and not working. If the process is needed, then we come up with an optimal algorithm, otherwise we discard the process.
Implementation of improvement actions based on the audit
Based on the results of the internal audit, report, has the following structure:
- General information about the state of affairs in the company in terms of quality management
- Critical non-compliance with the requirements of the standard
- Remarks
- Recommendations
Based on the report, a list of events to improve the QMS.
Rice. Internal audit report schema
Rice. Internal audit report template
Quality management report to top management
When the QMS is established and internal audits are carried out, the Quality Management Commissioner submits a report to the top management of the company, which contains an analysis of:
- Customer complaints
- Company market shares
- Corrective actions
- Preventive measures
- Internal audits
- Dedicated resources
- Work with personnel
- corporate culture
- Etc.
During this procedure, the authorized person "sells" the created system to the first person of the company, demonstrating to him all the benefits of using the QMS. Based on the results of the report, top management makes decisions on the final adjustment of the system, sometimes quite radically.
Rice. Agenda of the Report to Senior Management
QMS certification
When the QMS is completely ready, it is certified, i.e. confirmation by an accredited body that the created system complies with the standard. To put it simply, some reputable independent organization guarantees that your company works well and stably.
Certification has a number of steps:
- QMS is being developed
- Certification body selected
- Applying
- Documentation (quality manual) is sent to the certification body and checked in absentia
- The time of the certification audit is set
- Auditors check the working system. The number of auditors depends on the size of the audited company. During the audit, the auditors determine "critical deviations", comments and recommendations. If there are more than 3 critical deviations, then the certification is interrupted, the payment "burns out", and the next audit is scheduled. However, this happens extremely rarely.
It is worth noting that the cost of certification depends on the size of the company and the number of man-days of the auditor's work. The cost of one man-day of work of a Western certification body is equal to the monthly salary of an average Russian manager.
Repeat audits, continuous improvements, recertifications
Since the principle of continuous improvement was laid down in the QMS from the very beginning, so-called surveillance audits are carried out annually, and every third year - a mandatory recertification of the system.
So, the QMS has been created and is working. What did it give our company "Etalon"? A very simple and important thing - it has become more competitive and successful. And no matter what changes take place in the market, its shareholders and management are now sure that the company will be able to quickly adapt to them: not only save itself, but also reach a qualitatively new level.
With quality management, the winds of change become favourable!
What else?
Of course, there are other important aspects when implementing quality management in a company.
- So, for example, one cannot do without tools, of which more than 600 have been developed to date: from the simplest to the very complex.
- It is very important to work with the personnel correctly so that your QMS is not just a pile of paper, but a really working mechanism for increasing the company's competitiveness.
1 W. Edwards Deming, "Out of the Crisis." - Tver: Alba Publishing House, 1994
Competent and effective management organization is impossible without ensuring the quality of products. Quality Management System (QMS) is a part of the overall management system of the organization, which aims to ensure the stable quality of services provided and products. Enterprise QMS provides for the constant formation of policy, goals in the field of quality and the solution of tasks.
In accordance with the concept of quality management systems of the organization high quality production should be achieved not through constant monitoring of each unit produced, but due to the elimination of factors that may lead to errors and defects. The most common reason for marriage is wrong actions. To avoid incorrect actions, you need to describe them in such a way as to exclude the very possibility of incorrect execution. For this, instructions are developed for performing actions and controlling them. ISO Quality Management System regulated ISO 9000 series standards, which represent a unified version of the requirements that apply to the quality management of an enterprise. As required ISO standards organization's quality management system should include the following components:
- the company's quality policy, which specifies the goals and objectives, as well as ways to achieve them;
- a system of interrelated and mutually conditioning processes;
- regulatory framework, which is a set of regulatory documents in the field of quality. Regulatory documents should be developed in accordance with the system of formed processes;
- a mechanism for implementing the requirements listed in the documents of the regulatory framework of the quality management system;
- trained personnel of the organization who have knowledge of the policy, regulatory framework, the mechanism for implementing regulatory requirements, as well as the ability to apply this knowledge in practice. The personnel of the organization must respect and comply with the requirements of the quality policy.
Effective management system allows you to solve the following problems that every organization faces:
- Your specialists do not perform their duties efficiently and on time? The reason for this may be the fact that the regulations and instructions of your company are not systemic, are not arranged into a holistic enterprise regulation and do not reflect the existing life cycle management and production. Implementation of the management system will help streamline and systematize all the regulatory documents of your organization and ensure that employees clearly fulfill their duties.
- Do your specialists constantly sort things out with each other instead of doing their job? This situation is common in departments in which the system of interaction between employees is not established. After management system implementationISO interactions between employees will be clearly debugged, which will allow them to effectively perform their duties.
- Are management personnel mindlessly spending your company's money? The reason for this is that the management staff pays 40-60% less attention to the analysis function than to other functions. By using management systemsISO You will focus the attention of your managers on the analysis of past, current and future events.
- Are labor, time, financial, energy resources used inefficiently and extensively in your organization? The reason for this is too confusing procedure for making managerial decisions. Management systemISO optimizes the decision-making process and ensures its speed and efficiency.
- Do your employees not know what they are working for? Your company does not have clear goals on the basis of which the activities of departments and individual employees are built. Management systemISO will provide an opportunity to orient the staff towards achieving the goals and objectives of the company.
- You don't control the flows Money in your company? The reason for this is the lack of a process budget in the company, the disconnection of the budget from the regulations of the company. By using management systemsISO You synchronize your budget with every type of operation performed by the company.
- In your absence, work in the company is suspended? The reason lies in the lack of competence of the staff. And the consequence of this situation is that you work for your staff, and not the staff for you in order to achieve business goals. Having implemented quality management system, You can be sure of the competence of employees and their clear performance of their duties.
- Are your staff only working to get the job done faster, not to get their own satisfaction from the work done? Is he not interested in ensuring the quality of products and services? The problem is that your staff do not realize the importance of their activities and spend time at work solely for the sake of money. Management systemISO will allow to motivate employees to qualitatively fulfill the tasks set and to interest them in achieving better performance results.
The introduction of a product quality management system allows the organization to:
- ensure stable product quality,
- create a favorable image of the organization,
- establish long-term partnerships with suppliers,
- compete on equal terms with certified companies,
- increase productivity and reduce production costs,
- optimize information flows, eliminate duplication of functions, increase business efficiency,
- to orient the staff to achieve the goals and objectives of the company.
The body for certification of quality management systems and personnel "ISU" provides its services in the development and implementation of a management system. With the help of unique simulation and game modeling techniques used by the company, you will achieve a significant increase in the efficiency of the company by optimizing all its business processes. As a result of joint activities You will achieve:
- Increasing the performance of the company by ~ 20-30%;
- Improving the efficiency of its functioning by ~ 30%;
- Reduction of expenses from ~2-5% depending on the amount of current expenses;
- Reducing workflow by ~ 10-15%;
- Release of a temporary resource from top management by ~ 30%;
- Full transparency of the functioning and performance of each unit;
- Establishing clear goals and targets for all departments;
- Registration of interaction regulations with an accuracy of up to an indicator
- Leading in in electronic format departmental budgets;
- Development modern technology management;
- Willingness of staff to independently modify the management system in accordance with any new market requirements without the help of third-party consultants;
- 100% interaction between departments;
- The readiness of the organization to undergo a certification audit for compliance with ISO series MS;
- Complete readiness of the company to undergo a verification audit carried out by any third-party authorized organization;
- Obtaining a state-approved certificate on the completion of advanced training courses in the amount of 72 hours in the specialty "Quality Management System Manager".
At the same time, it should be noted that the QMS is not a universal means of solving all business problems, but only a means to improve its efficiency.
The quality management system (QMS) is part of the enterprise management system. Its goal is to ensure the stable quality of the services or products that the company produces. In this article, we will understand what a quality management system is. in simple words, we will give a step-by-step algorithm for its implementation and consider the role of the financial director in this process.
Documents confirming the stability, reliability and prospects of the company, such as reporting under IFRS or, have been supplemented with a certificate of compliance of the QMS with the requirements of ISO 9001. Proper implementation of the quality management system will allow the company to receive a number of advantages:
- improve manageability, competitiveness, quality of products and services;
- reduce costs;
- make the company customer-oriented.
SMC is...
A quality management system is a system that ensures efficient work companies, including in the field of product quality management. The most effective when creating a QMS are the requirements fixed in the international QMS standards ISO 9000 series.
Note that an effective system can be created without focusing on the ISO 9000 series standards. However, in order to certify it, that is, to obtain a document indicating that the company's processes are effective and aimed at constantly improving the quality of products or services, the QMS must comply with the requirements ISO 9001-2000 standard. Therefore, we will consider its creation from the point of view of the requirements of ISO 9001.
In order to build a QMS in accordance with ISO 9001 standards, it is necessary:
- develop a document that formulates the goals and objectives of the QMS, as well as the principles for achieving them (“quality policy”);
- develop regulatory documents describing and regulating business processes ();
- think over an effective mechanism for implementing the requirements regulated by the regulatory framework;
- prepare staff.
When forming all these elements, the basic principles of quality management should be taken into account. Consider the implementation of the QMS in stages.
Principles of building a quality management system
When building a QMS, one should be guided by the principles formulated in the ISO 9000 QMS standard:
- consumer orientation,
- leader leadership,
- employee involvement,
- process approach,
- continuous improvement,
- fact-based decision making
- mutually beneficial relationships with suppliers.
The model of a quality management system based on a process approach looks like this:
Stages of QMS implementation in the company
Let us consider in detail all the stages of the implementation of the QMS in the enterprise.
Stage 1. Management decision
The manager must decide on the start of the project, notify the company's employees, and also create the prerequisites for the rapid implementation of all other stages. At this stage, it is necessary to formulate the goals of building the system, highlight the processes that need to be controlled at the top level, and the criteria for assessing their quality. Subsequently, the goals must be recorded in a document called "Quality Policy", which also describes the principles for achieving them.
Stage 2. Personnel training
Personnel must understand the theory of quality management, ISO 9000 series standards, master the theory of the process approach, as well as the basic requirements for the implementation of the QMS. Training in the use of the system can be carried out both with the help of consultants and independently, if the company has an employee who has experience in setting it up.
Stage 3. Formation of the QMS implementation program
Implementation of the QMS is a complex and lengthy project for up to one and a half to two years. Therefore, it is necessary to draw up a program that should include:
- description of implementation stages;
- a list of people responsible for each stage of the project. As a rule, they are chosen from among top managers, as well as specialists who know best the specifics of the work of their departments;
- implementation budget. It includes both the costs of certification and the payment of consultants, if they are involved, as well as the cost of further staff training and the cost of distracting management from the main work for the project. When staging, you can do it on your own, however, distracting top management from the main work, as well as preparing own specialists the required level may cost more than the services of a consulting company;
- procedure for evaluating the implementation of the QMS. The criteria by which management will be able to determine whether it was possible to achieve the goals set at the beginning of the project are indicated.
After compiling the program, you can proceed to the direct formulation of the QMS.
Stage 4. Description and optimization of business processes
The described business processes must be optimized, that is, all non-compliance with the requirements of the standard and duplicative ones should be eliminated, as well as new ones should be developed in accordance with the rules of the standard. Most often, companies do not have a “Customer Satisfaction Assessment”, which is required by the standard. Therefore, it is necessary to develop a system of indicators, as well as procedures necessary for the implementation and monitoring of this process.
Stage 5. Development of regulatory documentation
At this stage, normative documents, regulations and procedures are formed that ensure the work of the QMS. The basis for them is usually a set of documents already existing in the enterprise, which is modified and supplemented in accordance with the requirements of the standard.
First, based on the "Quality Policy", a document called "Quality Manual" is prepared. It contains the main provisions governing activities: the delineation of areas of responsibility, requirements for the quality service, a description of the procedures for ensuring it, the procedure for maintaining the QMS document flow, a description of the complaint handling procedure, etc.
The next level of documents is called "System-Wide Documented Procedures". According to the ISO 9001 standard, six procedures should be carried out:
- document management,
- data management (records),
- audit management,
- management of products that do not meet standards (the process of identifying defects and the procedure for their disposal),
- management of actions that correct nonconformities,
- management of measures to prevent the occurrence of nonconformities.
The documents next level describe the rules for effective planning, implementation and control of processes. Such documents include working methods, job descriptions of employees, technological maps.
The basis of the "pyramid" of documents is data confirming that the requirements of the QMS are implemented in practice. These are reports on the work done, entries in the operation logs, etc., that is, the documentary basis of the daily work of employees.
When preparing regulatory documentation, it is necessary to take into account the requirement of the ISO 9001 standard on the competence of the personnel performing the work. This means that the regulatory documents should describe the process of employees' access to regulatory documentation, as well as the requirements for personnel competence (level of knowledge, work experience), a program to improve the level of employees if necessary, an employee motivation system, etc.
It should be noted that the effective use of a large number of regulatory elements requires the presence in the organization.
Stage 6. Testing and internal audit of the quality management system
After the development of all regulatory documents, trial operation begins. You can start processes gradually, for example, first introduce control over the procurement process, then production, etc. Pilot operation is accompanied by an internal audit, special procedures for checking work. At the beginning of operation, they are carried out frequently (perhaps once a week), then less frequently (once a month or even a quarter).
For internal audit purposes it is necessary to fix quantitative indicators of quality, for example, rejection rate, customer satisfaction rate, return rate, etc., to which it is necessary to strive. To determine the value of such indicators, similar indicators of industry leaders are usually used. Internal audits should identify inconsistencies between current work and the requirements of the standard. These deviations must be recorded. Then, based on the results of the audit, adjust the work of employees, as well as regulatory documentation, in order to avoid deviations in the future. All this work should also be documented.
Stage 7. Certification
In order to certify the QMS, it is necessary to submit an application to the certification body. Initially, a number of documents should be submitted to the certification body:
- certification statement,
- all documents (“Quality Policy”, “Quality Manual”; scheme organizational structure companies, documented procedures and other developed documents),
- list of the main consumers and suppliers of the enterprise.
Specialists of the certification body conduct an examination of the submitted documents within a month. The examination may include a visit by representatives of the certification body to the enterprise to check the QMS in operation. Based on the results of the audit, a protocol is drawn up in which all inconsistencies between the system and the requirements of the ISO 9001 standard are recorded. Usually, according to the results of the first stage of the audit, more than a hundred inconsistencies are found, and the task of the enterprise is to eliminate them as soon as possible and prove it to the certification body. As a rule, these operations take 1-4 months.
After that, the actual certification of the QMS is carried out. If all significant discrepancies are eliminated, the company is issued a certificate, it is issued for about a month. Repeated (surveillance) audits of the QMS are carried out by the certification body at regular intervals. They confirm that the company has not only implemented the system, but is constantly improving it. The cost of such an audit is approximately one third of the cost of primary certification.
The role of the financial director in the implementation of the QMS
Majority Russian enterprises have existed for a long time and work according to historically established rules. In order to change these rules in accordance with the QMS, a strong administrative resource is needed: the CEO and CFO must not only take an interest in such changes, but also manage them. Very often financial directors act as a coordinator of the process of building a system and are directly involved in the description and systematization of procedures within this work.
QMS staging sometimes pushes financial service to the preparation of financial and management reports for international standards. After all, accounting under IFRS and financial management in accordance with ISO are very close in their idea.
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