Quality Management System Planning

Accountability Objectives and Goals—This element encompasses continuity of operations, continuity of systems (resources and funding), continuity of organizations, company expectations (vision and master plan), the quality process, control of expectations, alternative methods, management accessibility, and communications. 

Top management plans and develops the processes needed for product realization. Planning of product realization is consistent with the requirements of the other processes of the quality management system (see 4.1). In planning product realization, the following elements are determined appropriate ... 

The first step is for someone in management to recognize the need for computer systems validation and to gather the other management expertise necessary to address the issue. This person is usually someone in the Quality Assurance Unit (QAU) or the computer operations, Management Information Systems - MIS, group. While these two departments need to be involved, computer systems users such as laboratory leaders, study directors, and other affected department managers need to be included in the development of a computer systems validation plan. 

Discusses any deviations from validation plan and quality issues found Management authorization to use the system... 

The ISO 9004 Quality Management and Quality Systems Elements—Guidelines provide standards and guidelines for quality management planning and implementation. 

Variable probability method (utility function assessment), 2193, 2194 Variable state activation theory (VSAT), 2209 Variable tasks, 740 Variance(s), 2367 homogeneity of, 2255 and hypothesis testing, 2249-2252 hypothesis testing for equality of means and, for k populations, 2255-2256 reduction of, 2492-2493 residual, 2270-2271 and testing for mean value, 2244-2249 Variant process-planning systems, 475-477 Variation, 1828-1855, 2266. See also Statistical process control (SPC) common vs. special causes of, 1828-1832 and improvement of quality, 1831-1832 in management of processes, 1830-1831 measurement, process tolerances vs., 1986-1987... 

The environmental evaluation system [7, 10] was designed by the Battelle Columbus Laboratories in the United States to assess impacts of water-resource developments, water-quality management plans, highways, nuclear power plants, and other projects. 

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