Knowledge Sharing Initiative of Value Added Corporate Services P Ltd, Chennai, India http://www.valueadded.in
Total Quality Management help the labs establish, manage and monitor a testing process to provide an appropriate Qualitative approach for its patient care services.
Feigenbaum first described Total quality management (TQM) in 1957. Since 1980, this has become an 
important management theory in Industry and Business. TQM takes into consideration the customers’ needs. Customers’ needs are defined through communication with physicians and other health care providers and helps a laboratory set up quality goals and criteria for an acceptable performance. TQM philosophy is derived from earlier concepts of quality control and quality assurance. Definition of TQM is not limited to just standard-setting and quality control, it encompasses all aspects of organizational management with continuous effort towards improvement. It concentrates on processes as well as products. It is centered on quality and long-term success, client satisfaction being a priority.
Commitment & Leadership
TQM is an approach to improving the competitiveness, effectiveness and flexibility of an organization for the benefit of all involved. It is a way of planning, organizing and understanding each activity, and of removing all the wasted effort and energy that is routinely spent in organizations. It ensures that the leaders adopt a strategic overview of quality and focus on prevention and not detection of problems. It involves everyone and to be successful, must start at the top with the leaders of the organization.
All senior staff and the middle-cadre demonstrate their seriousness and commitment to quality, and ensure they communicate the principles, strategies and benefits to the people for whom they have been given the responsibility. Only then will the right attitudes spread throughout the laboratories.
Leaders must take responsibility for preparing, reviewing and monitoring the policy, and take part in regular improvements and ensure it is understood at all levels of an organization. Effective leadership starts with the development of a mission statement, followed by a strategy, which is translated into action plans throughout the organization. These, combined with a TQM approach, should result in a quality organization, with satisfied patients and good results. The five requirements for effective leadership are:
• Developing and publishing beliefs, values and objectives, often as a mission statement
• Personal involvement and acting as role models for a culture of total quality
• Developing clear and effective strategies and supporting plans for achieving the mission and objectives
• Reviewing and improving the management system
• Communicating, motivating and supporting the lab staff and encouraging effective employee participation
The TQM Framework Involves
• Quality Laboratory Processes (QLP)
• Quality Control (QC)
• Quality Assessment (QA)
• Quality Improvement (QI)
• Quality Planning (QP)
• Quality Goals
Quality Lab Processes: This would describe the polices, procedures, personnel, standards, laboratory 
methods and system operating procedures for tests.
Procedure for monitoring the process: A good QC system helps to prevent detect and correct problems. Statistically quality control monitors analytical performance in relation to accuracy and precision. This involves external as well as internal quality control.
Quality Assurance: This monitors overall performance. It includes both analytical as well as customer satisfaction, which can be done by objective feedback. This should address the pre-analytical, analytical and the post-analytical phase. Turn around time, patient preparation, sample receiving, feed back from doctors and patients can serve as an indicator of QA of the pre- and post-analytical phase. External quality assurance and proficiency testing monitor analytical quality.
Quality improvement: This is the outcome of QC and QA. It helps to identify the source of the problem, 
leads to how to tackle the problems, followed by monitoring the problems till they are solved.
Quality planning: This is a prerequisite to quality assurance. It establishes and validates the process from both analytical quality as well as customer needs. It designs processes when one needs to adopt new methods or select new instrumentation. Quality planning also helps in designing appropriate QC programmes. It makes sure that quality aspects are not neglected and added at the last minute.
Quality Control Goals: This represents the requirement that must be achieved to satisfy customer needs. For analytical quality, the requirement is to provide test results that are accurate within the stated limits. Ultimately it is not a sample but the patient at the end of it who gets the results.
TQM Benefits: TQM adds to operation costs but in return ensures quality in the overall process. Since it starts at the top, an active and effective leadership with involvement gives an impetus to empowered staff. The aim is to reduce errors and thereby costs and to do things right the first time. The overall operation is transparent to all the staff. All this helps the lab to benchmark itself and move towards the next goal, which is accreditation.
