The TQM and Six Sigma, Essay Example

Introduction

With the competitiveness of the globally business environment the businesses are being forced to gain more and more effectiveness and efficiency. This enables the businesses to acquire a competitive advantage over its rivals and competition and also work towards sustaining the same. The businesses in an attempt to acquire all this adopt various strategies and policies, which will help the businesses in treading the path of efficiency, growth and development.

Quality Management Systems is one of these strategies, which the businesses adopt in order to have an assurance that all of the methods, practices and methods in the business adhere to quality. This report would elaborate on the significance of quality management in FDA (U.S. Food & Drug Administration) for HACCP systems. This system along with being logical based is based on scientific measures aimed at the protection and quality assuring of food. This toll is being established to ensure control of the food processing setup. It shall also act as a preventive measure and facilitate the prevention of hazards instead of merely testing it at the end.

The need of Quality Management Systems and Traceability

FDA systems comprise food item’s quality control and check. Therefore, it is utmost significance that the FDA systems function in accordance with the provided standards. It ensures that healthy ingredients are being used in all of the food products and all processes adhere to the quality standards. The ISO 9000: 2000 defines the traceability as initiating right from the raw material and products origin. Therefore, it may be defined as a process, which is following the food through all the stages it is passing through. FDA along with different regulations define two nature of traceability. The first of these is the internal traceability and the second is the chain traceability. The internal traceability comprises the different details and outlines, which the company follows in the processing of the food right from the raw material stage to the final product.

The second is the chain traceability, which pertains to the attention to information regarding any product linked with the chain (Allotey, 2003)

The general concern and the public concern regarding the quality and safety of food can now be deemed to be higher. This is because many of the recent incidents like the diseases found in the sources of meat including the cattle, cow and different other sources of meat like the mouth and foot diseases. These are the factors, which have driven the different like the organizations and also the FDA in this behalf to have the quality management systems implemented. As by means of these organizations can not only manage but also ensure the quality of the food. Moreover, by means of this they can also trace, control and ensure the entire chain the food is passing through.

It may therefore, be said that FDA itself serves as a quality measuring tool, which is used around the globe by various organizations. Yet, embedding this FDA with Quality management systems will serve to further enhance its reliability, effectiveness and authenticity along with that of the delivered outcomes. (Parker, 1995)

As previously discussed as a result of the changes in the consumer behavior and its increasingly getting health oriented; many restaurants now prefer to use green and eco-friendly ingredients in their products. They are adopting this to render their customers more satisfied and rendering their meals healthy according to the customer’s requirements. The similar trend has also led to organizations using up the standards in managing the quality and the tracing of the chain from the beginning to the end. (Kubr, 2002)

Role of Quality Management and Traceability

FDA by virtue of integrating quality management and possessing appropriate resources is more likely to generate better results. This can be explained by taking the example of various kinds of meat available. This ranges from white meat to the red meat; all the resources need separate issues in terms of the health concerns. Further as these industries are also faced with the need of diversification of their portfolio; an appropriate system which will effectively monitor and control the entire processing method of the various meals is needed.

It may be relevant to mention here that the need of the quality management systems and traceability in FDA is; for ensuring that the organization meets its objectives, standards in processing of food and the provision of appropriate resources for generation of raw material. Therefore, quality management systems along with traceability will result in effective methods for organization in order to obtain the best possible results. Along with the meat industries various other industries including the manufacturing sector and the service industries namely the agricultural sector have adopted these.

The main objective behind the quality management systems adopted by FDA is to assure the attainment of desired results not only in terms of quality but also in terms of the customer satisfaction. The international organization for standard as assurance has produced various series of standards like ISO 9001, 2000 (Rawlins, 2008)

FDA may benefit from the adoption of the quality management systems. These systems core objectives are to ensure quality right from the supplier till the consumers, thus for everyone involved. Therefore, it may be safely concluded as the set of activities by means of which the organizations ensure the continuous process improvement in efficiency and effectiveness in rendering the performance up to the standards (Sashkin & Kiser, 1993)

By virtue of these systems the FDA may boost their performance and deliver better results. This is because at the heart of quality management systems and traceability is the objective that these must trace the whole of the business process and enforce effective and efficient methods for delivering the results. FDA in perspective of the food industry will double the benefits attained by these.

Some of the benefits, which accrue to the organization as a result of adopting the quality management system concept, are

• The shift in the consumer behavior by virtue of the many health concerns can be better dealt and addressed by adopting these systems in the organization. This greatly enhances and assures the customer satisfaction. It also increases the probability that the company and its quality meet and in fact exceed the expectations of the customers.
• This also entails and better addresses the needs and wants of organization in dealing with the external and internal environment, also ensures the avoidance of extra cost in lieu of any process. To conclude, in order that the company obtains the optimum and the best out of the available resources and in being cost effective the entire process should be ensured to be efficient and effective (Schlickman, 2003)

It can therefore, be said that the presence and adopting of the quality management in the FDA will serve to enhance the companies food safety and overall quality. This will also ensure the prevention and rule out all possibility of hazardous material in the food and also its prevention and control so it may not recur. However, the attaining of the same level for an organization can’t be said to be an easy task. This is because it requires the presence of defined objectives, which the organization has identified. Also, supports the whole of the organization through each and every level, from suppliers to customers, thus all of the activities. (Mukherjee, 2006)

Quality management facilitates the FDA in attaining the objectives, which are entailed in the policy and also the different strategy. This system also enables the organizations to achieve consistency in terms of efficient and effective materials, processes and methods. For e.g. if the company is purchasing meat from the supplier then this system shall enable the company in being able to trace and track the kind of meat being purchased. In addition to these features also, its quality, tracing of the supplier and whether the supplier is providing the highest quality product.

An effective quality management system will also ensure that the FDA has improved and effective processes and systems. This will assure that the company is heading in the right direction in meeting the expectations of its customers; this will also enable the company in terms of improvement of the overall controls of the various processes. The company shall also reduce and eliminate the wastage, which is being generated from the various activities quite unlike in FDA’s system. The company shall also experience in this behalf cost reduction in the conduction of various operational activities. Especially in reference to the FDA the company shall be better able to reduce the cost and increase its market share; as this is more likely to satisfy the customers in a better manner (Bolton, 1999) Implementing Six Sigma in FDA

Six sigma, a project-driven management approach, is aimed at improving the FDA’s products, services and processes; six sigma does this by continuously reducing the defects, which exist in the organizations in any regard.  Six sigma is a business strategy, which aims at improvement this includes; financial performance, business systems, customers understanding, productivity and customer’s requirement. In the mid 1980s six sigma methods application facilitated the organizations in sustaining their competitive advantage. It does this by integration of their process knowledge with project management, statistics and engineering (Anbari, 2002). Various articles and books have provided an insight into the concepts and the benefits of the six sigma method (Harry and Schroeder, 2000; Hoerl, 1998, 2001). The successful implementation 0f the six sigma method is yet faced with immense challenges. Yet, the benefits derived from its implementation to the project driven and technological driven organizations are immensely rewarding.

Six Sigma in FDA

Six sigma in the business world is termed as a business strategy, which is aimed at improvement of the profitability of business in improvement of efficiency and effectiveness of the entire business operations; so these may meet the customer’s expectations. (Antony and Banuelas, 2001). The six sigma has gained wide spread application owing to the fact that the FDA were articulate the betterment derived from its application in their financial returns. The organizations did this by linking the improvements, which had resulted from its application with the cost savings, which had occurred because of it.

Six sigma is a systematic approach and a data-driven approach, which uses the DMAIC process (define, measure, analysis, improve and control) and also utilizing the design for the six sigma method (DFSS) (GE 2004).

Six sigma is a systematic, data-driven approach using the define, measure, analysis, improve, and control (DMAIC) process and utilizing design for six sigma method (DFSS) (GE 2004). The fundamental principle of six sigma is to ‘take an organization to an improved level of sigma capability through the rigorous application of statistical tools and techniques’ (Antony et al., 2003). It generally applies to problems common to production.

Anbari (2002) pointed out the fact that six sigma is far more comprehensive than any of the previous quality initiatives like TQM (Total Quality Management) and CQI (Continuous Quality improvement). Six sigma methods entail using of additional and advanced data analysis tools, usage of project management methodology and tools, measured and reported financial results, a focus on customer concerns. Anbari (2002) has summarized the six sigma management methods as follows

Six Sigma=TQM (or CQI) + Stronger Customer Focus + Additional Data Analysis Tools + Financial Results + Project Management

Design for Six Sigma

Five Step DFSS process (adapted from de Feo and Bar-El, 2002)

De Feo and Bar-El (2002) have summarized DFSS seven elements as follows.

• Successfully driving the customer-oriented design process with capability of the six sigma
• An ability to predict the design quality at the outset
• Matching of the top–down requirements that of flow down with capability flow up
• Integrating the cross-functional design involvement
• Driving of the predictability improvement and quality measurement in the early design phases
• Using the process capabilities in arriving at the final decisions
• Monitoring of the process variances to ensure that the customer requirements are being met

Benefits of Sig Sigma for FDA

The objectives of six sigma implementation are

• Reduction of cost
• Increasing the speed to the market
• Improvement of the R & D processes

In being able to measure the effectiveness of six sigma implementation the organizations need to consider and focus

• The improved project success rate
• Data driven reviews
• Integration of R & D into regular work processes.

Six sigma requires the active participation, contribution and dedication of the top management not only towards efforts but also towards the resources. The organization’s CEO is usually quite actively involved in the successful and effective six sigma implementation. The implementation of the organizational infrastructure would ask for well trained individuals. The implementation also requires the commitment of various resources

• Money
• Time
• Efforts

Obstacles and challenges of six sigma method

Issues in strategy

Hammer and Goding (2001) have argued that six sigma has often been the target of not merely criticism but also controversy in the quality community, which refer it to as Total Quality Management on steroid. One of the major criticism in this regard is that six sigma is not something, which may be termed as something new but merely is the repackaging of the traditional and existing techniques and principles, which are related to quality (Catherwood, 2002). Organizations need to realize that six sigma may not be the universal answer to all of the issues, which the businesses face and it also may not be deemed the most important strategy; which may lead to the organization’s feeling a sense of urgency in understanding and implementation of it. The ensuring of the long-term sustainability of the six sigma methods require analysis and acceptance of its strengths along with its weaknesses in the proper utilization of the six sigma tools, principles and concepts.

Issues in organizational culture

The quality concepts need to be integrated with the designing process rather than merely monitoring of the quality at the manufacturing stage. (McClusky, 2000)

One of the most important and effective issues is the organizational culture change, which imparts the aspect of quality into that of planning. The claims that six sigma is a success would be deceiving in addressing the issues and problems, which are easy to corrected.  Organizations which do not have a comprehensive understanding of the real hindrances, obstacles of the six sigma project and change management plan are more likely to encounter failure. A fact, which can’t be over emphasized, is the key management’s devotion, leadership, dedication and support in dealing with any of the cultural issues and the differences, which are related in the implementation process of six sigma. If these are not feasible and can’t be devoted then the organizations should probably not think of adopting and implementing the six sigma.

Issues in training (Belt Program)

A factor, which plays a key role in successful implementation of the six sigma project is training and should form a part of the integrated approach in this regard. The belt program i this regard should commence from the top and then be applied and implemented in the whole organization. The belt program curriculum should also be appropriately reflecting the needs and requirements of the organization. It should be customized in order to incorporate the managerial and the economical benefits. The training in this aspect should cover both the quantitative and the qualitative measures, metrics along with project management skills, practices and leadership. Here it is important to note that the formal training forms a part of the development plan pertaining to the production of the various belt level experts. Participants in this regard need to stay informed of the latest trends, techniques of the six sigma and also communicate with actual data analysis.

Future of six sigma

Six sigma shall remain as one of the key initiatives in improvement of the management process than merely being remembered as one of the fads (Johnson and Swisher, 2003). The primary focus needs to be on overall improvement of the management process and not merely on counting and pinpointing of defects.  Many practitioners and researchers are attempting to integrate six sigma with the existing innovative and effective management practices. These efforts are aimed at rendering the six sigma method more effective and attractive to the organizations, which have not yet implemented the six sigma method. The comparing and integrating of six sigma characteristics and principles with that of Total Quality Management Revere and Black, 2003), (Hammer and Goding, 2001), Human Resource Functions (Wyper and Harrison, 2000), Lean Production (Antony et al., 2003), ISO 9000 (Catherwood, 2002), ISO 9001 (Dalgleish, 2003). While, integrating this with the capability maturity model( Murugappan and Keeni, 2003) may all be rendered a part of the quality community effort to ensure maximization of the six sigma positive effects.

Conclusion

FDA has been introduced to enable and facilitate the organizations in determining the food ingredients quality. It also further ensures that the quality of each ingredient being used in the processing of food.  The traceability factor along with quality management systems will ensure that businesses are able to trace the entire track record of the product. This includes its source, its dispatch and thus each and every process the food is passing through.

The report has discussed the need of having quality management systems and traceability in the company. It also discusses the different benefits and features, which can accrue by adopting appropriate methods in reference with FDA systems; which shall enable the company in prevention of hazardous material and ingredients usage in the food.

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