Quality Management systems benefits

The intended audience for these guidelines includes those responsible for developing and implementing PSM and ESH management systems which could benefit from incorporation into a Quality Management system. This... 

To realize the benefits to a laboratory of a quality management system. 

Business Benefits of Establishing a Robust Quality Management System... 

This chapter will outline the concepts, benefits, and practical implementation steps for developing a comprehensive quality management system (QMS) that supports pharmaceutical and biopharmaceutical manufacturing operations. The material presented is universal in its utility, applicable to small and large companies, development, and commercial enterprises. A QMS is aproactive,structured approach... 

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. 

As it turned out, in general, pharmaceutical drug manufacturers already operating under GMP did not expect a marked benefit from being officially ISO 9000 certified. As a commonsense approach to take and combine the best of ISO and GMP, however, the use of a quality management system along the structure proposed by ISO 9000 became accepted practice in the industry. Manufacturers of API, on the other hand, and producers and suppliers of bulk chemicals, found the idea of getting the ISO 9000 certification quite attractive. 

Simply monitoring quality performance is just not adequate. The effectiveness of quality management systems should be actively managed and performance improvement opportunities seized. Business benefits should more than compensate for any investment in quality. Senior management, system owners, project managers, and anyone else involved with computer projects need to appreciate this. This book will help explain what needs to be done to successfully achieve quality and compliance of computer systems in the pharmaceutical and healthcare industries. 

The benefits of having a quality management system are that we have a form of internal quality control that allows us to have consistency of the service we provide. Our work will be verified, documents checked, and internal quality audits conducted. This means that we are continually assessing the practices set down in the documents of the quality management system. 

The outcome of the team s hard work will be the definition of the organization s best practices. One of the major benefits for an organization embarking upon the development of a quality management system such as the ISO 9000 is that it has to put its operations under close scrutiny. The saying if it isn t broken, don t fix it obviously applies in this situation, but often there is a tendency to be too conservative and attempt to certify the situation as-is rather than using the opportunity to... 

What are the benefits of applying a quality management system (QMS) as opposed to a traditional more informal approach simply relying on normal supervision The application of an effective QMS, by its definition of procedures, its recording of inspection and test results, and its mechanisms for detecting and correcting anomalies, apart from its direct benefits, will give the necessary assurance that quality ... 

Chapter 10 cites another management tool, that of periodic reviews of the site quality management system, giving a model list of areas of investigation. The necessity of a final site project report is underlined to enable lessons learnt to be fed into the corporate pool of experience and know-how for the benefit of future projects. 

The quality management system is described in the quality manual, which can be realized as an electronic documentation based on the hypertext technology (Figure 4). The benefits of the quality manual are ... 

Some approaches to quality management suggest that companies reduce the total number of suppliers for a service or material to just a few high quality entities. This allows the companies to symbi-otically develop relationships. Both parties can benefit greatly by using a system designed to rank preferred tollers. However, do not let the motivation to reduce the number of suppliers inhibit the critical review of potential tollers capable of performing the toll successfully. 

These data on improvement will be critical for justifying the full project. If the results are insufficient, there is a possibility that the full project will not be authorized. However, it is unreasonable to expect that the full benefits of integration will be achieved during the life of the pilot project. Some benefits are gained only as the staff become familiar with the new systems. You may be able to use experience of other quality management projects to forecast the full impact of integration. 

Due to the operating requirements of PEM stack technology, shift reactors and a carbon monoxide removal step are required to produce reformate of sufficient quality. Similarly, the stack operating temperature and its humidity requirements require a water management system as well as radiators for heat rejection. Some developers are developing pressurized systems to the benefit from higher reactant partial pressures on both anode and cathode. Fuel processing for PEM APU systems is identical to that needed in residential power or propulsion applications. 

An apparently high level of effort is required to report and investigate near misses. The costs of this effort are quantifiable. The benefits of these investigations are not as easy to tabulate. The actual number of accidents that have been prevented by improved near miss reporting may never be known. However, organizations that have seen dramatic increases in near miss reporting have also seen dramatic reductions in losses. The root causes of near misses of safety consequences may be the same management system weaknesses that adversely affect operability, quality, and profitability. 

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