complete details about tqm system in pharmaceutical industry
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TOTAL QUALITY MANAGEMENT BY:AMAN SHARMA M.PHARM (Quality assurance) 2020-2022
Meaning and Definition: Total Quality management provides the concept that ensures continuous improvement in an organization. The philosophy of TQM stresses on a systematic, integrated and consistent approach involving everyone and everything in an organization. It aims at using all people in multifunctional teams to bring about improvements from within the organization. Everyone associated with the organisation is fully involved in continuous improvement (including its customers and suppliers if feasible). Some of the important definitions of TQM are as under: “Total Quality Management (TQM) is an approach to improving the effectiveness and flexibility of business as a whole. It is essentially a way of organizing and involving the whole organisation, every department every activity, every single person at every level.” —Oakland “Total Quality Management is a combination of socio-technical process towards doing the right things (externally), everything right (internally), first time and all the time with economic viability considered at each stage of each process.” ADVERTISEMENTS: —Zaire and Simintiras “TQM is the systematic analysis, but the focus is turning from a process driven by external controls through procedure compliance and enhancement to a process of habitual improvement where control is embedded within and is driven by the culture of the organisation.” —Foster and Whittle “TQM is a strategic approach to produce the best product and service possible through constant innovation.” ADVERTISEMENTS: —Atkinson “TQM is a management system, not a series of programs, it is a system that puts customer satisfaction before profit. It is a system that comprises a set of integrated philosophies, tools and processes used to accomplish business objectives by creating delighted customers and happy employees. ” —Price and Chell From the above definitions, it is clear that TQM is a long term success strategy for the organisation, it aims at customer satisfaction, employee satisfaction, product quality at ail stages and brings about continuous improvements and innovations of total quality. TQM is a journey.
Importance of tqm The benefits arising from the implementation of a Total Quality Management in an organization are:This will increase the awareness of quality culture within the organization. A special emphasis on teamwork will be achieved. TQM will lead to a commitment towards continuous improvement.
The key principles of Total Quality Management Commitment from the management: Plan (drive, direct) Do (deploy, support, and participate) Check (review) Act (recognize, communicate, revise) Employee Empowerment: Training Excellence team Measurement and recognition Suggestion scheme Continuous Improvement: Systematic measurement Excellence teams Cross-functional process management Attain, maintain, improve standards Customer Focus: Partnership with Suppliers Service relationship with internal customers Customer-driven standards Never compromise quality Process Oriented: Thinking about the process Handling of the process Processes which are result oriented Decision Making Based on Facts Only and Not on Opinions: Integrated , strategic and systematic approach to ensure the entire organisation is aligned Communication must be open and at all levels of the organisation.
Essential requirements for successful implementation of TQM Commitment: Quality improvement (in all aspects) must be everyones ’ job in the organization. An apparent commitment from the top management, breaking down the barriers for continuous quality improvement and steps required to provide an environment for changing attitudes must be provided. Training and support for this should be extended. Culture: There should be proper training to effect the changes in attitude and culture. Continuous Improvement: Recognize improvement as a continuous process, and not merely a one-off program. Customer Focus: Perfection in service with zero defects and full satisfaction to the end-user whether it’s internal or external. Control: Ensure monitoring and control checks for any deviation from the intended course of implementation. Plan Do Check Act This is also referred to as the PDCA cycle. Planning Phase: This phase is the most crucial phase of total quality management. Under this phase, employees have to come up with their respective queries and problems which need to be addressed. The employees apprise the management of different challenges which they are facing in their day to day operations and also analyze the root cause of the problem. They need to do the required research and collect significant data which would help them find solutions to all the problems. Doing Phase: In this phase, a solution for the identified problems in the planning phase is developed by the employees. Strategies are devised and implemented to crack down the challenges faced by employees. The efficiency and effectiveness of solutions and strategies are also evaluated in this stage. Checking Phase: Under this phase, a comparison analysis of before and after is done in order to assess the effectiveness of the processes and measure the results. Acting Phase: This is the last phase of the cycle, in this phase employees document their results and prepare themselves to address other problems.
GENERIC STRATEGY MODEL FOR IMPLEMENTING TQM SYSTEMS Top management learns about and decides to commit to TQM. TQM is identified as one of the organization’s strategies. The organization assesses current culture, customer satisfaction, and quality management systems. Top management identifies core values and principles to be used, and communicates them. A TQM master plan is developed on the basis of steps 1, 2, and 3. The organization identifies and prioritizes customer demands and aligns products and services to meet those demands. Management maps the critical processes through which the organization meets its customers’ needs. Management oversees the formation of teams for process improvement efforts. The momentum of the TQM effort is managed by the steering committee. Managers contribute individually to the effort through hoshin planning, training, coaching, or other methods. Daily process management and standardization take place. Progress is evaluated and the plan is revised as needed. Constant employee awareness and feedback on status are provided and a reward/recognition process is established .
Beliefs about Total Quality Management Following are the universal Total Quality Management beliefs: Satisfaction of the customer/owner is the measure of quality. Everyone is an owner. Continuous Quality improvement must be there. Analysis of the processes is the key to quality improvement. Constant TQM is not possible without consistent, active and enabling leadership by managers at all levels. It is important to incessantly improve the quality of the products and services which we are supposed to provide to our customers/owners.
Case study: The major aim of the case study was to provide a practical example of how to use the TQM implementation model in practice. To achieve this goal, it is necessary to present the model to a firm and investigate how the firm uses it in practice . The case study was conducted in a state-owned large-sized machinery firm that had been established in 1958. It is located in Shenyang, Liaoning Province, P.R.China, and was a key and backbone firm of the country in manufacturing rubber belt conveyers. Its market share ranked third in China. Its products involved various kinds, varieties, and specifications and had not only been sold across the country but also enjoyed a high reputation in Southeast Asia. The firm had been implementing TQM for a long time and obtained ISO 9001 certification in 1998. Due to its good quality management, the firm was awarded the “Quality Management Prize” by the Ministry of Machinery Building and the Liaoning Provincial People’s Government a number of years ago. In 1998, the firm was conferred “Shenyang Advanced Management Enterprise”
TQM Implementation This subsection presents the weak areas of the firm’s TQM implementation and the reasons leading to these weak areas. Leadership: There was strong evidence that top management empowerment had not yet been implemented. The firm was centralized and hierarchical, and there was a strong tendency for employees to do things according to what they were told. They tended to wait for guidance from top managers or supervisors at all times. Thus, employees did not take any risk or responsibility if things went wrong; otherwise, they would be punished or fined. If things went wrong, employees tried to seek excuses to protect themselves in order to avoid being fined or criticized. Employees did not want to take any risk by doing things without permission. Supplier Quality Management: Long-term partnership between the firm and its suppliers had not yet been established. The firm had a special policy of rewarding purchasing personnel who could purchase products without immediate payment or less immediate payment. This was due to the shortage of capital. Otherwise, the firm could not have sufficient materials to maintain normal production. Such practices caused the problem that the firm would have to pay more in the future. In China, many firms have such policies that a buyer can purchase products at a lower price if the buyer can pay immediately. If the buyer can not pay immediately, the purchasing price is always higher. One interviewee said that it was very difficult for the firm to organize production
Vision and Plan Statement : The firm had a long-term vision statement that had been drawn up several years ago. However, many employees were not clear as to what the vision statement was. In fact, the firm did not use it as a guide in formulating its business strategies. In this regard, the general manager did not have a clear long-term vision. The reason for this was that the general manager had been appointed by the administrative bureau to run the firm on a short-term basis, based on a contract. If he performed well, he would stay in the position longer. The decision made by the bureau in this regard was highly dependent on the firm’s annual business performance. Therefore, the general manager focused on annual business performance rather than long-term business success . Evaluation: Although the firm tried to improve a number of job-related facets that might affect employee satisfaction, the employee satisfaction level as a whole remained unclear to some extent. Competitive benchmarking with its major competitors was not conducted by the firm. Thus, TQM implementation and overall business performance of its main competitors remained unclear to a certain extent. Thus, the firm lost opportunities for further improvement of its quality of products and services. In fact, this practice had actually not caught top management’s attention. The data on appraisal costs and prevention costs were not available. The firm mixed these two types of quality costs with the firm’s normal overhead expenses. Thus, it was not clear as to how much money was spent on appraisal and prevention. It is no doubt that the firm spent a great deal of money on various inspection activities, as it had approximately 30 specialized inspectors. Many inspection activities were actually non-value added. In fact, the availability of appraisal costs and prevention costs was valuable to the firm in formulating effective improvement actions so as to reduce these costs. The firm did not have an integrated computerized information system for collecting, processing, analyzing, disseminating, and storing relevant information. Information technology remained at a primitive level. Thus, it was difficult for different departments and workshops to share their information. The firm’s major information flow was through handwritten documents. Therefore, working efficiency was low and some problems occurred due to the poor information system. The firm did not have such a computerized information system in place due to its pursuit of immediate profits and short-term benefits.
Process Control and Improvement The firm did not pay sufficient attention to determining an appropriate temperature range, lighting intensity, noise level, and air quality. During the process of conducting the case study, the author observed that several windows were broken and a number of lights and electric fans were turned off. Such practices were due to the fact that these workshops wanted to reduce costs in order to increase profits. It was evident that various workshops tried their best to reduce any cost that they could .
Product Design Concurrent engineering for product design was not effectively implemented by the firm. Designing products through cooperation among different people from various functional departments, suppliers, or customers had not been achieved. Generally, only the R&D department was involved in product design and the technology department was in charge of auditing various drawings of product design. Contract review and design review were not sufficiently implemented. Thus, a number of quality problems occurred during production and with products in the field. The firm did not focus on modular design in order to make the product more producible. Designers tended to change product design drawings constantly. NOTE: In view of time consumption I am shorting this case study further shorten it in my own words that firm does not follow other important TQM elements like quality system improvement ,employee involvement ,education and training , customer focus .which affects their business and market value.
Discussion and Conclusions Based on these weaknesses, the firm’s targeted improvement area of overall business performance, and the firm’s available resources, an improvement plan was formulated. The firm’s deputy general manager agreed that the firm would implement this improvement plan in practice. Thus, it can be concluded that this TQM implementation model can be used to evaluate the firm’s TQM implementation and overall business performance, identify strengths and weaknesses therein, and assist the firm in formulating the improvement plan. Therefore, the TQM implementation model developed in this study is applicable to this firm. This magically affects the overall performance of the industry in the market and customer base for the company
Conclusion A successful TQM implementation requires a significant training for the employees involved in it. Since the training program can take employees away from their day to day work, this eventually can have a negative short-term impact. Also, since Total Quality Management tends to result in a consistent series of incremental changes, it can lead to creating an unpleasant response from those employees who prefer the existing system, or employees who are afraid of losing their jobs because of it. Total Quality Management works best in an environment where there is strong support and commitment from the management.