INTRODUCTION:

Quality cannot be tested into products but it should be built-in or should be by design. Quality improvement is a systematic approach to the processes of work that looks to remove waste, loss, rework, frustration, etc. in order to make the processes of work more effective, efficient, and appropriate. Teams use the quality improvement methodologies (QIM) to decide what they want to improve and are thus empowered to improve their work conditions. Quality improvement team members are selected for their expert knowledge of the process being improved or other special skills. Such teams can continually seek opportunities for improvement, design, test, and implement solutions without requiring higher authority to initiate the effort. Following are Quality improvement methodologies (QIM) which arise and recognize the opportunities for quality improvement and quality management¹.

QUALITY IMPROVEMENT METHODOLOGIES:

International Organization for Standard - ISO 9000

ISO 9000 is a family of ISO (The International Organization for Standardization) standards for quality management systems.

The ISO 9000 standards are maintained by ISO and administered by accreditation and certification bodies. There are 6 documents that ISO specifies which given in Figure-1

In addition to these, ISO 9001:2000 requires a Quality policy and Quality manual. ISO 9000:2000, sought to make a radical change in thinking by actually placing the concept of process management front and centre in the standard. Documents produced by the ISO Technical Committee (ITC) which drafted the third edition make it clear that they didn't see any change in the essential goals of the standard, which had always been about 'a documented system' not a 'system of documents'. The goal was always to have management system effectiveness via process performance metrics^{1, 2}.

Total Quality Management –TQM

Total Quality Management (TQM) is a management approach for an organization, centered on quality, based on the participation of all its members and aiming at long-term success through customer satisfaction, benefits to all members of the organization and to society. TQM has been widely used in manufacturing, education, government, and service industries. TQM process steps are shown in Figure-2.

Quality assurance through statistical methods is a key component in a manufacturing organization, where TQM generally starts by sampling a random selection of the product. The sample can then be tested for things that matter most to the end users. The causes of any failures are isolated, secondary measures of the production process are designed and then the causes of the failure are corrected¹.

Figure-1: Documents required according to ISO standard

Figure-2: Process steps of Total Quality Management (TQM)

Six Sigma:

Six Sigma (6σ) is a methodology to manage process variations that cause defects. It was pioneered by Bill Smith at Motorola in 1986 and Motorola has reported over US$17 billion in savings from Six Sigma to date. Six Sigma was originally defined as a metric for measuring defects, improving quality and a methodology to reduce defect levels below 3.4 Defects Per Million Opportunities (DPMO). Six Sigma identifies and prevents defects in manufacturing and service-related processes. The objective of Six Sigma is to deliver high performance, reliability and value to the end customer. Six Sigma strength is its ability to turn a practical problem into a statistical problem, generate a statistical solution and then convert that back into a practical solution by using DMAIC process (Define, Measure, Analyze, Improve, and Control) and DMADV process (Define, Measure, Analyze, Design, Verify). DMAIC is used to improve an existing business process and DMADV is used to create new product designs or process designs. Sometimes a DMAIC project may turn into a DFSS (Design For Six Sigma) project because the process in question requires complete redesign to bring about the desired degree of improvement¹.

Lean manufacturing:

Lean manufacturing is a management philosophy focusing on reduction of the seven wastes like over-production, waiting time, transportation, processing, inventory, motion, scrap in manufactured products. Key lean manufacturing principles are described in Figure-3¹.

Figure-3: Important Lean manufacturing Principles

Failure Mode Effect Analysis – FMEA:

Failure Mode and Effects Analysis is an easy to use and yet powerful engineering quality method that helps you to identify and counter weak points in the early conception phase of all products and processes. The structured approach makes it easy to use and even for non-specialist a valuable tool. FEMA is a methodology for analyzing potential reliability problems early in the development cycle where it is easier to take actions to overcome these issues and thereby enhancing reliability through design. FMEA is used to identify potential failure modes, determine their effect on the operation of the product and identify actions to mitigate the failures. A crucial step is anticipating what might go wrong with a product. While anticipating every failure mode is not possible, the development team should formulate as extensive a list of potential failure modes as possible. A Failure Mode Effect Analysis (FMEA) is an analytical technique utilized to assure that, to the extent possible, potential failure modes and their associated causes have been considered and addressed. FMEA is widely used as an analytical tool in the pharmaceutical manufacturing industries³.

Malcolm Baldrige National Quality Award – MBNQA:

Malcolm Baldrige was Secretary of Commerce from 1981 until his death in an accident in July 1987. The Malcolm Baldrige National Quality Award is given by the President of the United States to businesses manufacturing, service, education and health care organizations that apply and are judged to be outstanding in categories given in figure-4. Any organization headquartered in the United States or its territories may apply for the award, including U.S. subunits of foreign companies.

Figure-4: The MBNQA performance excellence criteria

The criteria are designed to help organizations enhance their competitiveness by focusing on two goals: delivering ever improving value to customers and improving overall organizational performance⁴.

Process and Analytical Technology – PAT:

PAT is considered to be a system to design, analyze, and control manufacturing through timely measurements (i.e., during processing) of critical quality of materials and processes with the goal of ensuring final product quality. The goal of PAT is to understand and control the manufacturing process, which is consistent with our current drug quality system. Using this current approach of building quality into products, this guidance highlights opportunities for improving manufacturing efficiencies through technological innovation and enhanced scientific communication between manufactures and the agency. An emphasis on building quality into products allows a focus on relevant multi-factorial relationships among material, manufacturing process, and environmental variables and their effects on quality. These relationships provide a basis for identifying and understanding relationships among various critical formulation, process factors and for developing effective risk mitigation strategies (e.g., product specifications, process controls, training). The data and information to help understand these relationships are obtained through preformulation programs, development, scale-up studies and manufacturing data collected over the life cycle of a product^5,6.

European Foundation for Quality Management (EFQM) excellence model:

The EFQM excellence model is a framework for quality management systems, promoted by the European Foundation for Quality Management (EFQM) and designed for helping organizations in their drive towards being more competitive. The EFQM Excellence Model is a practical tool to help organizations do this by measuring where they are on the path to excellence, helping them to understand the gaps and then stimulating solutions. The EFQM Excellence Model is a non-prescriptive framework based on nine criteria. Five of these are 'enablers' and four are 'results'. The 'enabler' criteria cover what an organization does. The 'results' criteria cover what an organization achieves. The EFQM Excellence Model is a practical tool that can be used for self-assessment, way to benchmark with other organizations, guide to identify areas for improvement, the basis for a common vocabulary, a way of thinking and structure for the organization’s quality management system^7,8.

Statistical process control – SPC:

Statistical process control (SPC) is a method for achieving quality control in manufacturing processes. It is a set of methods using statistical tools such as mean, variance and others to detect whether the process observed is under control or not. Classical quality control was achieved by observing important properties of the finished product and accept/reject the finished product. As opposed to this technique, statistical process control uses statistical tools to observe the performance of the production line to predict significant deviations that may result in rejected products. By using statistical tools, the operator of the production line can discover that a significant change has been made to the production line by wear and tear or other means and correct the problem or even stop production before producing product outside specifications. An example of such a statistical tool would be the Shewhart control chart^9,10.

REFERENCES:

1. Stanley A, Berman P, Flynn M. Fusion Management: Harnessing the Power of Six Sigma, Lean, ISO 9001:2000, Malcolm Baldrige, TQM and Other Quality Breakthroughs of the Past Century. QSU Publication Company, 2003.

2. Brian R. Standards ISO 14000 and ISO 9000. Gower Publishing Company; 76 (2); 1997. p. 60.

3. Robin EM, Raymond JM. The Basics of FMEA. Productivity Press; 1996. p.56.

4. Maureen SH, Gregory FG. The Malcolm Baldrige National Quality Award: A Yardstick for Quality Growth. 1st ed. Addison-Wesley Publication; 1995.

5. Katherine B. Process Analytical Technology: Spectroscopic Tools and Implementation Strategies for the Chemical and Pharmaceutical Industries, Wiley-Blackwell Publisher; 2006. p. 28-30.

6. Katherine B. Process Analytical Technology, Wiley-Blackwell Publisher; 2006. p. 06.

7. Annie Persaud. Using the EFQM Excellence Model Within Health Care, a Practical Guide to Success. International J. Health Care Quality Assurance. 2002; 15 (4): 141.

8. Chris Hakes, The EFQM Excellence Model to Assess Organizational Performance - A Management Guide. Van Haren Publishing; Best Practice Series edition; 2007. p. 11.

9. Abraham B, Birkhauser Verlag AG. editors. Introduction Quality Improvement Thought Statistical Methods. A Birkhäuser book; 1998.

10. Charles A. Cianfrani, John E. ISO 9001:2008 Explained, Third Edition, ASQ store; north America. P. 12.

Received on 14.12.2009 Accepted on 20.02.2010

Asian J. Management 1(1): Jan. – Mar. 2010 page 01-03