Pharmabiz
 

Pharma quality management

S K KaulWednesday, February 4, 2004, 08:00 Hrs  [IST]

Globalization and increasing domestic competition have brought a sense of urgency in inducting highly successful total quality management techniques in Indian pharmaceutical organizations. In the period before the 1950s, the onus of buying a good quality product was on the buyer himself, though this shifted towards a system of product warranty in sixties, when the manufacturers started taking, at least, limited responsibility for their products. This also started the advent of the statistical quality controls concept. In the 1970s quality became the cornerstone of Japan to make its industry competitive and it started producing high quality products. Later, by employing quality principles in controlling process waste, it was realized that quality could not be restricted any longer to a designated quality department, but it was to spread across the company, giving birth to the concept called "Total Quality Management" or TQM. TQM marks the beginning of new era, in which managers will focus on customer values, cross-functional systems and continuous improvements. This paper presents the basic ideas and components of TQM. The managerial skills required in the new environment and various techniques like benchmarking and business process re-engineering are also outlined. Quality is never an accident. It is always the result of high intentions, sincere efforts, intelligent direction and skillful execution. It is an attribute or characteristic whose dictionary meaning is the degree of goodness or worth of a person, place or thing. In determining the quality of a product, the customer's expectations about the product will be given the top most priority. In the present scenario, customer delight is the need of the hour in order to survive the cutthroat competition. There are different approaches through which the concept of quality can be under stood. According to the product-based approach, quality is an attribute, which can be measured quantitatively. The manufacturing based approach on the other hand, uses universal definition of conformance to requirements. The value-based approach says that the consumer purchase decision is based on consistent quality at an affordable price. The TQM Concept In this age of liberalization, the quality of products has become a major concern for pharma industries. To be competitive, an industry needs to provide a product/service, into which quality is designed, built, marketed and maintained at the most economical cost, which brings in customer "delight" instead of customer satisfaction. These competitive edges made the pharma industries think of approaching quality management efforts in their total form, known as Total Quality Management. The job of quality management is not just advising a sampling plan for the acceptance/ rejection of the incoming materials or products and controlling manufacturing process conditions. It is in fact a job at every stage of the company's activities. Quality Management is a company wide activity, involving the combined efforts of various departments such as R & D, engineering, purchase, production, Quality Control, Quality Assurance, Human Resources, Marketing, Distribution, Warehouse, etc in different phases with a view to achieve the desired quality of the end product. Quality awareness must begin at the very conception of the product and continue through various stages of development and manufacture & even during its use to get feedback from the users, which is essential for continuous product improvement. The TQM Vision The quality cycle begins and ends with the user. It starts when the user's need is analyzed to design a product. During the development & manufacture of that product, various departments and sections of the company make their contributions in building quality into it. The cycle ends with the user because the final proof of the product quality comes during its use by the user, whose "delight" is the ultimate aim of this concept. Quality is no longer the exclusive domain of the inspectors, manufacturers and pharmacists. Even Sales personnel have their role to play in the achievement of the primary objective of quality. Quality Management, as does any management process, has three main components: 1. Quality Planning - Designing the desired & deliverable quality standards. 2. Quality Implementation. 3. Quality Monitoring & control. It is imperative that TQM efforts should be properly organized to co-ordinate the various contributing aspects of quality. As such we need to know the basic ideas behind TQM. Organizations are made up of a complex system of customers and suppliers. People pay attention to who supplies them; with what they need to do their job and who the customer is for what they produce. When everybody becomes concerned about meeting their customers' requirements, quality will be there, without doubt. In meeting customer expectations the focus must be on the process, not just on the results. To improve a process it is important to look at the socio-cultural issues of organization to create a healthy, open atmosphere in which people are willing to open up and do some introspection on their processes. And this is something the management must be able to facilitate. In contrast to traditionally managed organization, TQ managed organizations believe that, though there is no complaint from the customers, there is always scope for improvement. Everybody in the organization is trained to plan & participate in groups. Meetings & Brain storming sessions become primary vehicles for planning & creative problem solving. Each member in the team is recognized & rewarded. Errors and problems are viewed as opportunities for learning rather than blunders to be punished. In the recent past, TQM got its formal recognition by way of ISO 9000. In order that organizations may successfully compete with world-class leaders, it is imperative to look at and be prepared for quality way beyond the popular ISO 9000. In the context of the Indian organization, the common perception held is that quality improvement is uneconomical since it increases cost and investment, thereby decreasing productivity. Traditional Indian managers are not prepared for intense global competition where quality, cost, sticking to the deadlines and customer satisfaction are of paramount importance. They are not prepared to shed the belief that they can get business by cornering licences, influencing the bureaucrats. Domestic managers are unaware of the momentous changes taking place. Ironically even today most Indian managers rely more on market gossip and collecting random data than paying an accredited agency for factual information. Indian companies should wake up to the realities and try to build up an organization where information flows freely; employees are empowered with decision-making and problem solving, where teamwork is awarded and encouraged. Our executives have to learn how to become successful quality managers, so that they can become global managers and this primarily means change in their mindset. The key word here is "professionalism". Many managers have trouble fully trusting their employees. It is not surprising that many new managers want to keep control firmly in their own hands, but TQ managers see their employees as a work group and believe that their team wants to do a good job. The manager must learn skills of collaboration. He is to make certain his team has had the correct training in the use of data and statistical tools. Management by fact is the main characteristic of TQ manager. He should also reward the deserving team or individual for their support of the TQM philosophy. Recognition and reward are his key tools and he has to know how to use them in order to support TQM. He should help employees to gain insights from their personal experiences and how to improve on them thereupon. Many companies in India are realizing this and are now focusing their efforts on team building and teamwork. Hindustan Lever Limited, a Unilever group company operating in India, started implementing quality assurance in place of Quality Control. Looking at the success of quality assurance, the company started TQM in 1990; mainly to focus on intensified broad based training at all levels, institutionalizing quality improvement programmes, vendor development & certification. TQM Techniques Benchmarking: For many companies benchmarking has become a component of their TQM Programme. In most developing countries like India, until recently almost all the industries had a few number of products and services, which differed markedly in their utilitarian characteristics. However, such a situation is hardly sustainable with increasing competition from foreign goods and services. In such a situation, competing firms have to continuously improve. The benchmarking approach not only provides a comparative profile, but also helps the management to identify innovative products and services. "Benchmarking is a continuous process of measuring one's products, services & practices against toughest competitors". It will search for the best practices in the industry, which will lead to superior quality goods. With the growing emphasis on quality, it has got great significance in the present competitive world. If best practices are followed, customer requirements can easily be met, leading to increasing profitability of the company. But the employees resist change in the beginning because they are habituated to old processes. Efforts to change mindset of employees must vigorously continue till desired effect is achieved. Business Process Reengineering: Business Process Reengineering generally redesigns processes & the organization that performs them in order to reduce the number of boundaries crossed. Each time a process crosses an organizational boundary, opportunities for errors arise. Business Process Reengineering is the fundamental rethinking and radical redesign of Business Processes to achieve dramatic improvements in critical contemporary measures of performance, such as cost, quality, service and speed. Precautions: Wherever the responsibility of quality management is to be delegated to different departments, it should be done with many precautionary measures, thereby ensuring monitoring & control is in the hands of quality management people. The hierarchy structure of quality management should be kept to as few levels as possible and the span of control should be as broad as possible. As the traditional organizations are unable to meet the present challenges, there is every need for new techniques & philosophies with which organizations can survive and thrive under grueling competition. To retain their competitive edge, company should change their traditional ways of working, to read their customer's mind. No organization can afford to overlook customer, competition & change, the three vital forces of today's competitive environment. TQM is an important milestone in the ongoing evolution of the field of management. (concluded) -- The author is Sr. General Manager - Corporate Quality Assurance, Medreich Sterilab Limited, Bangalore

 
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