Abstract
BACKGROUND:
The history of Total Quality Management (TQM) presents a broad overview of the processes used to make things perfect in this imperfect world. The concept of TQM strategy in biochemical industries highlightsnumerous ways to use “quality” as a tool for improvement in the real work environment during the actual execution of work. A sustainable and effective quality management policy with specific missions and objectives mightlead to the achievement of a productive outcome in biochemical industry.
OBJECTIVE:
This study focused to examine the variation in understanding of TQM in the biochemical Industry and its correlation with other aspects of organizational improvement. To study the impact of TQM on a sustainability aspects of biochemical organizations by framing an appropriate synthetic model.
METHODS:
The strategic to setup a ‘hard’ and ‘soft’ TQM principles was used for effective TQM implementation. In addition, individually developed methods of TQM quality award models were implemented in a wide range of industries.
RESULTS:
This study reveals that, a significant number of biochemical industries recognize that sustainable business strategies and successful implementation of TQM practices lead to new opportunities and improves results in the economical and sustainable development.
CONCLUSION:
Appropriate policy-making strategies and TQM are critically important ingredient for organizational growth. The implementation of TQM in biochemical industries is important for the overall growth of the organization and employees.
Keywords



Introduction
In terms of management perspective, Total Quality Management (TQM) is a tool that presents innovative cases of organizational success. Total Quality Management is an integrated organizational effort designed to improve quality at every level. It mainly deals with a prototype and an organizational culture designed to upgrade quality performance in any organization, including the biochemical industry. The total turnover of Indian biochemical industries between September 2008 and 2009 was US$ 21.04 billion [1] and Indian biochemical industries are the third largest in the world by volume and 14th in terms of value. On the other hand, the issue of sustainability in the biochemical industry figures prominently in contemporary discussions of natural resources, environmental management, economic development, and sustainability through various policy-making strategies [2, 3]. Indeed, the long-term sustainability of biochemical industries mainly depends on the strategic implementation of certain policies at different levels. However, the TQM and sustainability aspects are not only limited to biochemical industries but also play a crucial role in severalsectors. Those are knowledge management for organizational innovation [4], mediation analysis through a Structural Equation Modeling (SEM) approach [5], and technology adoption for online purchasing [6], among others. The sustainable policy-making strategy has gained tremendous attention in recent years as It is directed towards satisfying ‘customers’ needs and expectations while respecting societal values and obeying government regulations.
In biochemical industries, certain studies have been underway to develop a linkage between quality management practices and their impact on organizational performance. For instance, the biochemical industries, which transverse from air, water, and soil pollution to climate change, are carved into the global landscape [7]. In this context, ongoing efforts are directed towards environmental sustainability by reducing water pollution, consumption of hazardous waste, energy consumption, etc. Total Quality Management practices manage environmental health, safety, and sustainability through vigilant and robust procedures that eliminate hazards in the pharmaceutical industry. Therefore, the major objective of TQM in a biochemical industry is to contribute for good health and well being of individuals and communities at large.
Produce quality work at the first time. Focus on the customer’s expectations. Construct a strategic approach for organizational growth. Consistency in the overall performance. Encourage mutual respect and teamwork.
Overall, the simple objective of TQM is “Do the right thing, right the first time, every time”. The TQM philosophy mainly focuses on teamwork, customer satisfaction, cost effectiveness, and implementing quality at all levels of the organization. To identify areas for improvement, irrespective of the size of organizations, the biochemical industries in recent years have implemented TQM by encouraging managers and employees to collaborate across functions and departments, as well as with customers and suppliers [8, 9]. For successful implementation of TQM, it is important that teams of workers are trained and empowered to make proper decisions to help their organization achieveahighquality standards.
Theoretical critique and research gaps
Evolution of total quality management in the biochemical industry
Prior to the evolution of ‘Taylor’s Theory’ of specialized workers in his scientific management principles, some of the aspects of TQM mainly dealt with the pride of the employee in his work methods, specifically in biochemical industries [10]. In order to ensure the level of failures caused by low quality, quality inspectors were introduced in the production section. In a biochemical industry, quality inspection thus becomes a routine activity [11]. Around the 1950 s, all levels of workers in biochemical industries adopted the concept of quality control and assurance as an integral part of their manufacturing work. In this line of quality management, the notation ‘quality circles’ was formulated by Ishikawa in 1960 [12] to eliminate inner-unit variation and improve the manufacturing processes. Subsequent improvisations over the concept of quality finally gave birth to the idea of ‘Total Quality Management’ in Japanese industries during the 1970 s. TQM as a concept demonstrated quality-oriented strategies and techniques as the main focus for the quality movement. Further, during the next few decades down the line, numerous biochemical industries introduced quality management procedures in line with the results seen in Japan.
In fact, TQM was hardly adaptable in the early stages of its evolution when it was applied to the manufacturing sector. As a proof of concept and practical case study for TQM implementation [8], two drug manufacturing companies in Chennai(India) were chosen, and responses from 100 employees were collected. Pearson’s correlation was employed to study the effect of TQM principles on employee remuneration. On the basis of analysis, the views of the respondents, shown that the TQM principles and its effects have a direct correlation with each other. The critical success factors (CSF) are the important areas of managerial planning and action that must be practised to achieve effective quality management in a business unit. They are critical and absolutely essential for the success of TQM. The TQM algorithm for the firm was demonstrated as follows:
Where
i = 1, 2, 3 . . ...I;
m = 1, 2, 3 . . .. M;
I = Total number of QAPs (Quality-related Action Programs) of the firm, which is also called as CSF (Critical Success Factor).
The implementation of TQM and its sustainability have not only been found to be effective in last several decades but also during the COVID-19 crises in recent years [13–20] across the globe. For instance, the COVID-19 crisis has consistently influenced environmental behaviors, as it primarily decreased income and disrupted food systems worldwide. Total quality management effectively helps to achieve insightful results through longitudinal studies employing probability sampling with larger samples [21].
Effective TQM has several advantages, as it indirectly relates to the customer and is equally important in improving quality at every level in the organization. Indeed, biochemical companies across India and the globe follow the principle of TQM to deliver high levels of service and high-quality drugs through sophisticated manufacturing practices without causing environmental hazards [22]. They also include financial benefits by integrating cost reduction, higher returns on sales and investments, and the tendency to charge higher prices than competitive ones. Subsequently, a few more advantages mainly cover friendly access to national and international markets, improved customer retention, new innovation within a short time, and a quality firm with a high reputation. In recent years, it has been noticed that only small biochemical industries use TQM because effective implementation of the program mainly involves more time, effort, finances, and consistency [1]. Indeed, the biochemical industries with the required resources may get competitive benefits in their industries by adopting TQM practices.
Strategic approach for implementation of total quality management in the biochemical industry
The important and primary step in implementing TQM is to investigate the present situation of the organization by accessing the reality of the firm. However, to access the reality of the firm, one should know the history of the organization, its current needs in terms of TQM and the present employee’s conditions and work culture. The TQM implementation will get delayed if the implementer does not have knowledge about the current realities of the firm. In other words, TQM in biochemical industries can be smoothly implemented when the organization has a track record with the history of management audit. The organization should be healthy before implementation of TQM, and therefore, the yearly audit is considered an important assessment tool to investigate the current level of organizational functioning and identify the areas where improvement is needed. The TQM is a strategic method employed in the organization by which management and employees are mainly involved in the continuous improvement process of the production of goods and services. In a biochemical industry, the desired objectives of TQM cannot be easily achieved with minimum organizational and human resources. It is a sum of quality and management tools targeted at increasing business and reducing losses, presumably due to wasteful practices. TQM is a proven strategy that has yielded significant financial benefits for many pharmaceutical companies [7]. Beck hard and Pritchard (1992) have outlined the basic steps in managing a transition to a new system such as TQM, identifying tasks to be done, creating necessary management structures, developing strategies for building commitment, designing mechanisms to communicate the change, and assigning resources. This continuous improvement is the result of the commitment of top management and the involvement of suppliers, customers, and the workforce. This involvement at all levels leads the organization to fulfill customer expectations [23].
Hard and soft approaches in the TQM principle
The strategic establishment of ‘hard’ and ‘soft’ TQM principles is one of the important aspects of effective TQM implementation [24]. The first approach is known as a standard-based approach and explains the implementation of new standards in the biochemical industry. It provides managers with standardization and administrative protocol for control of employees’ activities and outcome analysis [25, 26]. On the other hand, this method does not consider the customer as a part of the quality improvement plan and is therefore not considered to be very effective, as it focuses mostly on the organizational requirements of the company. The second relevant approach is based on quality award models. Here, TQM plays the role of a self-assessment tool for companies and is continuously acknowledged by various organizations that are responsible for presenting the awards. This method encourages companies to focus not only on administrative functions and their quality, but goes beyond that. The third approach includes individually developed methods of TQM implementation, which can be applied in a wide range of industries. Overall, this study demonstrates that all three of these approaches can work as guidance for TQM implementation in the strategic development of biochemical industries.
As stated by the International Institute for Sustainable Development [7] for the biochemical industries, the success pathway of sustainable development mainly consists of three distinct phases: Environmental compliance. Environmental risk management. Strategies for long-term and sustainable development.
This study reveals that, a significant number of biochemical industries recognize that sustainable business strategies lead to new opportunities and improved results in the economical and sustainable development phases (Fig. 2).

Economic performance and sustainable development of biochemical industries.

Environmental management system in biochmical industry.
This observation demonstrates that, in the context of consistent improvement in biochemical environmental management system, TQM practices purely depend on the environmental policies created by each country. Moreover, it also depends on the planning implemented for the connection of manufacturing services with the environment. Therefore, the strategic implementation of TQM and the corrective action plan lead to the consistent improvement of the biochemical industries and authorize safer future without compromising the sustainable development of the organization. Overall, sustainability is an integral part of systems theory, and it helps maintain balance between economic, environmental, and social aspects [27–29]. For example, the environmental sustainability of tourist attractions has required applications for tourism management and cultural heritage protection. A study demonstrates that tourist visit’s flow at destination attractions can negatively impact the environment and ecological settings [29]. It also demonstrates that diverse teams and leadership are likely to develop environmental strategies that contribute to sustainable mechanisms. This study also speculated that women were more likely to focus on environmental sustainability when leading tourism enterprises. However, men had shown their interest in being part of economic sustainability. This observation allows us to construct a relationship between TQM in line with the sustainable development of biochemical industries, health sectors, etc.
Based on the literature review and research gaps identified, it has been noticed that certain areas are still need to improve and in this context following research questions are framed:
Research questions
RQ1: To identify the appropriate strategies of TQM and corrective action plan lead to the consistent improvement of the biochemical industries. RQ2: To identify the environmental policies created by country and monitor planning implementation of manufacturing services with the environment.
Research objectives
Based on the significance of the subject and research gaps identified, the objectives of this review article are to: Examine the variation in understanding of TQM in the Biochemical Industry and its correlation with other aspects of organizational improvement. Study the possible impact of TQM on sustainability components in the disaggregated term. Design a synthetic model (framework) on the impact of TQM on routine as well as sustainability aspects of biochemical organizations.
Theoretical development and justification
The study dwells on a largely qualitative research approach using relevant existing literature and studies from reliable sources with an SLR (Systematic Literature Review) approach. To justify this approach, around 40 literatures were searched from the most reliable academic sources. Then, they were examined in terms of ‘eligibility for inclusion’. This means the papers that explicitly talk about TQM and sustainability in biochemical industries were reviewed. The ones that did not qualify these criteria are removed from the final analysis. Finally, 25 fully eligible literatures were taken for detailed analysis. A detailed content analysis of varying conditions was undertaken in terms of their relevance and theoretical development in the form of synthetic framework (Fig. 3) has been conducted.

Synthetic framework.
Textual analysis from literature
The Table 1 presents different aspects of the biochemical industry that correlate with TQM concepts in general. It also shows a possible impact on sustainability. The corresponding illustration is briefly described below in the form of a synthetic framework (Fig. 3).
Association of TQM with sustainability
Association of TQM with sustainability
The manufacturing technology in the biochemical industry developed due to high-end micro sophisticated manufacturing techniques beneficial to the formulation of zero-defect products. According to TQM practices, a zero defect product is required for the economic growth of the biochemical industries. The Table 2 demonstrates the relationship between TQM and its direct relevance for sustainable development. For instance, the implementation of appropriate TQM practices has a fruitful impact on the global environment, economic environment, operational performance, and so on.
Relationship between Total Quality Management(TQM) and sustainable development
Illustration of factors affecting TQM and its importance in the biochemical industry
Advantages and disadvantages of traditional and digital models of selling in the pharmaceutical industry
The Indian biochemical industry mainly includes Indian multinational companies such as GlaxoSmithKline, Merck, Pfizer, etc. However, Indian owned companies such as Ranbaxy, Dr. Reddy’s, Cipla, Glenmark, Cadila, and several more small-scale industries are located across India. These companies can be further classified based on annual turnover, number of patents, number of employees, and number of formulations. The studies [30] have been made to investigate and review the Quality Management Practices such as ISO implementation, as a part of TQM in Indian biochemical industries. In this context, a special questionnaire was used in the research by Kakkar and Narang [31] as per the specific requirements of the Indian biochemical industry. First, the questionnaire was circulated to the group of respondents in the Indian biochemical industry as part of the pilot study. Later, on the basis of responses received in the pilot study, the important factors affecting the implementation of TQM are summarized as: Top Management Commitment, Leadership, Quality Management, People Management and Training, Customer Focus and Supplier Quality. The importance of these factors in the context of the Indian pharmaceutical industries is tabulated below.
The responses from the pilot study were encouraging. Statistical analysis showed a clear linkage between Total Quality Management practices and performance in Indian biochemical industries. A similar strategic approach has been adopted during the COVID-19 pandemic for crisis management and mental health challenges and implications [14]. Here, the strategic approach of the study mainly focuses on educating people through social media platforms, which helps to overcome mental health consequences and there by the global health crisis [32].
Causes of failure in total quality management
TQM is critical in the biochemical industry because it is a management philosophy and manufacturing program me that aims to continuously improve and sustain ably develop product and process quality. However, failure of TQM in certain cases might occur due to several aspects, such as financial instability to complete the basic needs, weak administrative systems, alack of skilled manpower, poor employee morale, etc. Some studies [33] have proven that, when quality efforts fail, they yield marginal results. According to Brown, Hitchcock, and Willard (2012) the failure is mainly due to the following factors: Focusing only on short term financial results to the exclusion of system improvement. Quality improvement requires a change in thinking to manage the underlying systems. Interfering of managers in teamwork. Sloppy procedures and processes. Lack of understanding of the TQM approach. Many layers in the organizational structure. Lack of adequate training and education. Limited resources.
Limitations of TQM
Despite numerous benefits of TQM and its strategic implementation in the biochemical industry, it has a notable limitation. One of the main limitations of TQM is the need for company-wide commitment to quality improvement and its own difficulty in achieving this commitment. All levels of management must be ready for the program to be truly successful. Any minor lack in effort or resources can affect the success of a TQM program, which leads to negative impact which ripples throughout the company. If management fails to fully implement a TQM program, its partial efforts are bound to fail. For instance, just limiting the initiative to personnel training without making use of statistical tools to measure and evaluate process changes will create frustration and inadequate results. Training programs need to be taken full circle through evaluations and measured outcomes.
Further, TQM is generally a time-consuming project and requires leadership’s commitment to cascade the message through the organization. Problems arise when there is a management shift or business distraction that results in a loss of focus. Also, the company must recognize it is a continuous process. New hires need to be indoctrinated into the TQM mindset. Team members must be open-minded and considered equals.
The policy-making strategies in biochemical industries
For the sustainable and long term growth of biochemical industries, strategic implementation of key policies has been adopted in recent years [34]. In order to achieve sustainable growth and survive in a globalized and dynamic world, biochemical industries must be able to swiftly and effectively adjust to new conditions [35–37]. Basically, biochemical industries are engaged in a critical undertaking of research, development, and marketing of drugs to patients. Under these complex circumstances, the top management and personnel of the company must adhere to a number of important corporate policies which mainly important for the growth of the organization. A few key policies are briefly summarized as follows: Digitalization of the pharmaceutical industry
In the last decades, biochemical industries are resistant to digitalization, mainly due to fair experience and complexity of the entailed development and manufacture processes. However, in recent years, it has been observed that, there is a clear need to digitalize biochemical industries due to the constantly growing demand for both traditional and new drugs [38]. Therefore, in a biochemical industry, digitalization is a key step for the improvement and growth of an organization which ultimately leads to employee satisfaction and work efficiency. In this context, the strategic implementation of certain digitalization policies has recently been implemented in biochemical industries. These policies mainly consist of increased use of robotics, automation solutions, and computerization, thereby reducing costs, improving efficiency, and productivity ultimately being flexible to changes.
For instance, in a case study by Kumar et al. [39] found that only 11% of the health care professionals preferred in-person visits from the sales force. Recently, patients have also been very careful and willing to learn medical knowledge online using digital platforms and not merely relying on ‘only physician’s words. Because of technology, the highly challenging environment of industry market is getting more sensitive and converted to favor patients and medical staff. Unless the existing pharma sellers use newer technologies, the new players may take advantage over them by supplying information platforms, analytics, e-consultation services and access to online medicines. This transformation from the traditional to the digital era would threaten the old school of thought among pharmaceutical sellers and organizations in India. There are certain pros and cons to both the traditional and digital models of selling in the pharmaceutical industry. Managing carbon emissions
In order to control air pollution, it is important to follow certain policy guidelines in biochemical industries to maintain carbon emissions. In recent years [40] for managing the carbon emission, every biochemical industry has had to go through the strategic implementation of certain policies, which mainly include, shifting to renewable energy, planting trees to enhance energy efficiency, etc. Indeed, biochemical industries are more specific about lowering energy consumption every year, creating more energy efficiencies, and trying all efforts to generate sustainable electrical energy derived from renewable sources [41]. Since, biochemical industries release hazardous and bio-medical waste, it has been made compulsory to be prepared to meet a target to reduce water consumption and minimization through rainwater harvesting, recharge of groundwater, high pressure water cleaning systems, recycling facilities, etc. Therefore, to meet this target, biochemical industries across India targeted to increase hazardous waste co-processing through the maximization of technological development. Moreover, packaging waste minimization, co-processing, recycling and ensuring maximum utilization of electronic equipment’s through maintenance are the important strategies undertaken for maintaining waste disposal in biochemical industries. Thus, implementation of these policies in a timely manner supports a TQM philosophy and helps the green innovation process in the biochemical industry.
Sustainability of policy making strategies in biochemical industries
Implementing the sustainability of implemented policies in biochemical industries, mainly those producing biochemical products from renewable resources, is a key parameter for development. As part of sustainable development, strategies based on renewable energy resources are considered for power generation [32]. In recent years, India’s energy consumption has been increasing at a relatively fast rate due to population and economic growth [39] and therefore, the government of India is now making various strategic plans and policies in the energy sector. This includes reduction in energy poverty, increasing locally produced energy and more focus on developing alternative sources of energy, particularly nuclear, solar and wind energy. In this context, the Ministry of Renewable Energy of India has developed several policies for biochemical industries by providing various subsidies and incentives [43]. In addition, similar strategies has been implemented to achieve a sustainable growth in developing country, with in-depth analysis of the strength and weaknesses of feasibility and practicality in biochemical industries [44, 45].
Conclusion
The implementation of TQM in biochemical industries is important for the overall growth of the organization and its employees. The TQM in the biochemical industry can only be achieved by a well-organized work culture and complete employee engagement at the workplace. For the sustainable growth of biochemical industries, important policy-making strategies and regulations need to be adopted rigorously. Thus, quality is a critically important ingredient to organizational success today, which can be achieved by TQM, an organizational approach that focuses on quality as an overachieving goal aimed at the prevention of defects rather than the detection of defects. The study reveals in its conclusion that sustainable development is the organizing principle for meeting human development goals. At the same time, sustaining the ability of natural systems to provide natural resources and ecosystem services would be the key to development. Overall, the insights from this study provide some food for thought about how to utilize the best quality management techniques, such as TQM, with more confidence about their impact on organizational performance and sustainability, with special emphasis on the biochemical sector. In addition, this review provides the in-depth understanding of Human Research Management as we have demonstrated the TQM and various policy making strategies that can be implemented in pharmaceutical industries. We believe that, emphasis provided in this review surely helpful for the societal developments and interesting for the readers of human research management.
Contributions of this study
The contribution of TQM in pharmaceutical industry as covered under this review paper is reflected by continuous development of quality of the products through involvement of the employees and management in the whole process. The theoretical contribution of this very concept is clearly explained by the first part of the above explanation of the review. This dwells on both management and science theories such as Fredrick Taylor and Newtonian theories as corroborated by Dooley et al. [46]. This review also reinforces practical contribution of TQM in terms of a comprehensive analysis of benefits of the former in the pharmaceutical industry in India with respect to various parameters. Andersen (1999) makes a critique of industrial benchmarking as an aspect of TQM for competitive advantage [47]. In addition, the review explicitly presents the importance of implementation of sustainable policy making strategy and its correlation with the societal development, employee development and overall growth of pharmaceutical industries has been elaborated [3].
Footnotes
Acknowledgments
The authors are thankful to the anonymous reviewers for their valuable comments.
Author contributions
CONCEPTION: Satyajeet Nanda and Jijabai B. Rakte
METHODOLOGY: Satyajeet Nanda and Ramesh B. Dateer
DATA COLLECTION: Jijabai B. Rakte
INTERPRETATION OR ANALYSIS OF DATA: Ramesh B. Dateer and Satyajeet Nanda
PREPARATION OF THE MANUSCRIPT: Jijabai B. Rakte
REVISION FOR IMPORTANT INTELLECTUAL CONTENT: Jijabai B. Rakte and Ramesh B. Dateer
SUPERVISION: Satyajeet Nanda
