Continuous improvement defined

Another significant benefit of a LIMS is the improvement of the overall quaUty of the laboratory. In the case of a laboratory, quaUty is defined as satisfying customer needs in the areas of accuracy, reUabiUty, clarity, and timeliness of analytical information. LIMS can enhance quaUty in a number of ways, eg, in checking conformance to requirements, in organizing and prioritizing work to ensure timeliness, in measuring laboratory performance in areas of technical quaUty and efficiency so as to provide continuous improvement, and in helping the laboratory to communicate clearly, completely, and consistendy (16). 

The company has shown adequate evidence that a well-defined system is in place and documented which addresses the area in question. Ultimate goals may not have necessarily been reached however, the company is well on their way towards continuous improvement for the specific question/area. 

Goals and objectives to be defined Determination of customer satisfaction Continual improvement Analysis of data... 

A list showing examples of possible continuous improvement techniques is included in the standard. These techniques and many more are defined in Appendix A and a bibliography is provided in Appendix C. 

An inventory management system should be established - meaning set up on a permanent basis to meet defined inventory policies and objectives approved by executive management. It should be documented - meaning that there should be a description of the system, how it works, the assignment of responsibilities, the codification of best practice, procedures, and instructions. The system should be planned, organized, and controlled in order that it achieves its purpose. A person should therefore be appointed with responsibility for the inventory management system and the responsibilities of those who work the system should be defined and documented. Records should be created and maintained that show how order quantities have been calculated in order that the calculations can be verified and repeated if necessary with new data. The records should also provide adequate data for continual improvement initiatives to be effective. 

Many companies have adopted Total Quality Management as a way to promote continuous improvement in a broad range of business applications. TQM considers all business activities as processes, each one of which involves specific customer-supplier relationships. These relationships may be entirely internal, defined in terms of the process under study. For example, delivering efficient electronic mail service is a "process" in TQM terms. The "customers" for your company s electronic mail system are the employees who use it the "supplier" may office services, MIS, or other support personnel. 

Most QI programs build upon an established quality assurance (QA) process. Quality assurance can be defined as a formal and systematic process in which problems in delivering health care are identified, solutions to the problems are developed and implemented, and follow-up monitoring then is carried out [30]. QA begins with problem identification. After possible sources of the problem are determined, solutions are developed and implemented. Then, the results of the intervention or solution are evaluated to determine whether or not the problem has been resolved. By incorporating a goal of continual improvement, a QA process can contribute to quality improvement activities. 

The laboratory shall establish, document, implement and maintain a QMS and continually improve its effectiveness. Laboratory processes are managed in a way that ensures the effectiveness of the QMS and the continual improvement of the laboratory operation. The laboratory processes and their sequence and interaction shall be defined and their effective operation shall be considered. Such effectiveness is ensured by the provision of the necessary resomces and information. The effective operation of the laboratory processes is monitored on the basis of the achievement of the planned residts. The output of this monitoring process is the improvement in the overall laboratory function. 

The chapter is organized as follows. First, to establish a common language, we define some common terms from both a pharmaceutical and an engineering perspective. Subsequently, we review model-based design and optimization as a framework for product and process development and optimization, process scale-up, and continuous improvement activities. The role of process and analytical technology (PAT) methods and principles in this framework is discussed. Finally, the main areas requiring effort are identified. 

Quality System (QS) Formalized business practices that define management responsibilities for organizational structure, processes, procedures, and resources needed to fulfill product/service requirements, customer satisfaction, and continual improvement. 

Transforming disparate processes into processes that are simple to understand, easy to execute, and provide a sense of accomplishment meet one of management s obligations to staff. Staff interest lies in the ability to perform their work, contribute to continuous improvement, and have a reasonable work-life balance. Finally, they want to be able to contribute to their careers, have defined career paths, and have attainable development goals for advancement. A well-designed quality management system can contribute to provide all these employee benefits. 

Theme Level 1 (No Formal Approach) Level 2 (Process Defined) Level 3 (Proactively Managed) Level 4 (Continuous Improvement) Level 5 (Best in Class)... 

Promotes best practices Clearly defines quality standards Establishes measurable quality and compliance outputs Offers a rating system Management determines the priorities for correcting deficiencies Identifies areas for improvement Provides process to identify genesis of deficiencies and lack of or need to improve the quality system Fosters continuous improvement, total quality management, and forward quality thinking... 

Once processes have been established, the functions required to implement the processes shall be defined, e.g., equipment sterilization, environmental control such as temperature, differential pressure, particulate control, etc. It is at this stage that we must define the function performance criteria that will provide the basis for design, testing, operation, maintenance, and ultimately continuous improvement. 

Creative design processes are not properly understood. Neither routine tasks nor the experience of senior developers is properly captured. The complex coordination tasks on the management level in a multi-project and multi-team environment are not made explicit. The dynamics inherent to creative design processes is not captured. Therefore, the design process is not transparent for the project team. Intuition and experience have to compensate the lack of a properly defined work process and of a systematic reengineering of the work process for continuous improvement. 

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