Lucky devils

Anatoly Afonin, the Director General of JSC "Saratovorgsintez"

"Our enterprise has already been certified to confirm that our quality management system meets of ISO 9001:2000 requirements. This certification was a logical continuation of our efforts to improve the quality management system, as well as the management system of the entire enterprise.

The certificate is issued for three years, with inspection audits performed every half a year. The inspections will be carried out by BVQI that issued the certificate.

For a lot of companies the most difficult stage of the certification is the preparation of documentation in accordance with the international standards. While preparing these documents we did not apply for services from consulting firms. We already had some experience in the development and introduction of a quality management system in accordance with ISO 9002:1994 requirements at our enterprise. So we decided that the best option was to organize training of our specialists and then to use them for preparing the documentation and performing in-house inspections.

For us, as well as for a lot of other companies the certification is dictated by the market. It enables us to strengthen the position of our products in the domestic and international markets. It enhances our competitiveness in tenders, helps us promote our trade mark and improve our image".

Alexander Zelenov, the Director General of JSC "Voskresensk Mineral Fertilizers"

"Our enterprise was the first in the fertilizer industry to introduce ISO 9000 QMS. Its urgency was brought about by the appearance of production capacities in those countries that only consumed phosphate fertilizers previously, as well as by more stringent requirements to the product quality on the part of our European customers. Besides, domestic consumers started to inquire whether this or that manufacturer has a certified QMS. So, the introduction of such a system is not a matter of fashion, but necessity.

When we started to introduce QMS, we had to perform a huge work of revising and systematizing the documentation and modifying existing regulations. This work required active participation of both production and administration staff. It made us assess many things from a different viewpoint, pay more attention to discipline, and respect our consumer. The new requirements made it necessary to train our personnel and upgrade its qualification.

Now we analyze the QMS efficiency and its contribution to the operational results of our enterprise all the time: at board meetings, at meetings that review quality or operational results. When developing our QMS, we used a process approach with the following pattern: "internal supplier - executor - internal consumer". A ten-point multifunctional scale was introduced to evaluate all processes. The scale is also applied for self-evaluation. Here I want to emphasize that in some cases the results of our self-evaluation were worse than those by the customer and, fortunately, never the other way round. In 2002, we had 0.08% of inadequate quality product (in particular, ammophos), while in 2003 this percentage went down to 0.03 %. So, the system obviously works.

To be open to the customer and to respect him we have to permanently analyzed his opinion. Our marketing department sent 152 questionnaires to our customers in 2003. By a 10-point scale, the customer satisfaction factor was 8.6 points in the first half of 2003 and 9 points in the second half of 2003. The average satisfaction factor was 8.8, while our self-evaluation was only 8.6. As you can see, customers evaluated our work higher than we did.

The introduction of a quality management system demands that you are always at your best. German auditors from TUV CERT performed a supervisory audit of JSC "Voskresensk Mineral Fertilizers" on July 7-10, 2003 to check the results of the introduction and operation of our ISO 9001:2000 QMS.

The auditors confirmed that the system had a positive effect upon product quality in our company. They especially pointed out the success of ammophos shop No. 2 and several management departments. The TUV CERT auditors made no critical remarks.

Certainly, we will go on with this work. A part of our produce serves as a feedstock for manufacturing other goods. Therefore, we intend to certify our production of ammonia, phosphoric and sulfuric acids". First steps

Yuri Shaposhnik, the Director General of JSC "Ammophos"

"For us, a quality management system is the main tool for controlling both the restructuring and management of our production process. In our opinion, an ISO 9001 certified QMS helps to achieve this goal.

We want to make the international certificate the business card of our enterprise.

The QMS is being introduced under my personal supervision. We work in accordance with the integrated program that was developed and approved in advance. The list of processes to be certified has been compiled. In the first quarter of this year we will complete the development of QMS documented procedures. We are also getting ready for internal audits, preparing for auditor training, and developing process measurement methods. The major part of standards and regulations are at various stages of coordination. In February, we restructured the department that deals with the preparation for certification. I hope, this effort will enable us to accelerate our work and raise it to a higher level.

One of the most complicated problems of QMS designing is to distribute responsibility and powers and to establish personnel coordination at all levels by eliminating duplicated functions and engaging the personnel in all management aactivities. This work needs a lot of time, because human psychology can't be changed at once, whereas the system productivity, to my mind, depends on how many employees are involved in the management process. Our company newspaper "Chemist" has special space dedicated to this subject. We also plan to operate a "hot" telephone line. The QMS development team and the management of JSC "Ammophos" will have to hold a lot of meetings with our work collectives.

As to the financial expenses, we'll have to spend about half a million rubles for the certification proper and about as much for training and consulting. The principle results of our preparatory work will show by the middle of the year. If another training session is necessary, we'll have it organized.

We selected the certification authority following the example of JSC "Voskresensk Mineral Fertilizers", which has already introduced such a system and makes full use of it. First of all, we analyzed international certification bodies by the following basic criteria: pricing policy, frequency of certification tests, market recognition, etc. Then we chose TUV CERT as the most authoritative with our customers".

The other party

Konstantin Timoshechkin, BVQI CEO

"Our company was one of the first to appear in the Russian certification market. It was registered on the territory of Russia as an established certification center in 2000. We made ISO 9001certification audit of such chemical enterprises as "Nizhnekamskneftekhim", "Nevinnomyssk "Azot"", "Saratovorgsintez", "Saratov Oil Refinery", ISO 14001 and OHSAS 18001 certification audits at "Nizhniy Novgorod Oil Refinery", "Perm Oil Refinery" and so forth.

I must say that chemical enterprises show a great interest in QMS certification lately. This fact is related to the fact that the requirements to a quality responsible business become more stringent, while management standards are actually represented a set of the best business practice.

On the whole, chemical enterprises have no difficulties in preparing for the audit, since their multistage technological processes, which often use hazardous substances, were always rigidly controlled by technological instructions, strict discipline, and regulated business procedures. It is highly important that company management and personnel realize what the certification is needed for, understand that it enables them not only to operate in the international market with more freedom, but gives them a powerful control tool in the form of a well-tuned management system. An audit is not a police inspection. Its primary tasks are to check whether standard requirements are complied with and to improve the best practice. We do it by detecting deviations from the requirements and by taking corresponding corrective actions. If the certification body and the enterprise work as partners, the efficiency of the process is much higher.

The cost of certification depends on the volume of audit and the complexity of business processes. There exist rigid rules set by the International Accreditation Forum (IAF) for calculating those volumes. So, I doubt that certification bodies of the same level differ much from each other by their tariffs and total audit cost".

Pharmaceutics: GMP or ISO?

Tatyana Sboeva, Chief of laboratory of JSC "Organika"

"Our enterprise has developed and is now introducing a product quality control system. As we know, quality is a critical factor that supports and improves the competitiveness of each enterprise. Successful enterprises make quality their strategy and introduce quality management system that meets ISO 9000 standards.

Pharmaceutical enterprises are "special" enterprises, since they produce not a simple product, but a medicine. So, the introduction of GMP standards is mandatory for them. Here the question arises: can and should ISO 9000 standards be applied to the pharmaceutical industry, where enterprises are regulated by GMP standards?

The ISO standards are inter-industrial. They are phrased in general expressions, and their introduction is aimed, first of all, at the enhancement of enterprise competitiveness. The GMP regulations are a quarter of a century older. They are applied only to pharmaceutical production, reflect its specifics and protect the human health.

The GMP regulations do not provide for the improvement of product quality, since its qualitative characteristics are fixed in registration documents and cannot be altered without the permission of the body that cleared the preparation for use. On the contrary, the ISO 9000 standards provide for a continuous improvement of product quality based on the analysis of customer satisfaction. The ISO standards, however, do not mention some things that are very important for pharmaceutical production, namely, the prevention of product contamination, the requirements to production premises, the validation of technological processes. They lack sanitary and hygienic requirements and descriptions of specialists that should occupy key positions. On the other hand, the ISO standards feature a number of items not provided for in GMP standards: economic aspects of quality, marketing quality, market monitoring, product development quality, application of statistical methods, metrology, quality management.

Despite these distinctions, both documents are based on the same assumption: the analysis of an end product cannot guarantee its quality. The quality can be guaranteed only by a well-organized production. Other similar elements of quality assurance are input control, production process parameter control, finished product testing, availability of required documentation.

We believe that to design a QMS a pharmaceutical enterprise can use ISO standards, but the GMP regulations must be taken into account by all means. Our enterprise started to develop QMS by setting the "Documentation Management" standard, which specified what documents are necessary for QMS operation and categorized the documents used at the enterprise.

Another enterprise standard "Production Management" describes a system that performs quality management in the process of production. In this document we specified the basic processes described by process instructions, such as product development, production launch of a new medical preparation, logistic support, product manufacturing, finished product control, metrological, technical, power support.

To move forward, one has to analyze the existing system and, certainly, the level of customer satisfaction. Each customer's quality complaint is to be thoroughly analyzed, its reasons disclosed, and measures to prevent such cases in future worked out. Such a procedure enabled us to reduce the number of quality complaints on the part of our customers (14 complaints in 1999, 7 - in 2000, 3 - in 2001).

There is no doubt the introduction of QMS improves the image and reputation of the enterprise, increases the labor productivity and profit, enhances the quality and competitiveness of the produce, and improves the quality of managerial decisions".