Organizational changes

Independent Validation Departments should be established to demonstrate impartiality in regard to pressures from system development and operation functions. Typically, the Validation Department might be expected to reside under the QA umbrella. One problem to date many pharmaceutical 

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Organizational changes that may have an impact on process safety Variance procedures Temporary changes Permanent changes... 

TQM has frequently been used to focus on and improve processes in order to meet customer requirements, but not necessarily to look beyond processes for integration opportunities and organizational changes. Thus, it may need to be used in conjunction with another Quality Management system for the purposes of integrating PSM and ESH activities. 

The three case studies that follow demonstrate how mentoring can be used in organizations to support and enable organizational change. 

Returners were immediately more effective and up-to-date with organizational change. 

Some of the potential new problems to be taken into account arise from organizational changes. Taking part in a supply chain means to give up - at least... 

During the examination of the information from the FACTS database, it became clear that most accidents could be linked to changes or alterations in the company. These include not only technical and organizational changes, but also alterations in human staffing. 

Baram M., 1998. Process Safety Management and the Implications of Organizational Change, in Hale A., et al. (Eds), Safety Management, the challenge of change, Pergamon, Oxford, pp. 191-205. 

In an attempt to understand the factors which lead to a successful and acceptable implementation of a robotic system, Molet et al. [2] have described the history of the implementation of a robotic installation in the steel industry in France. TTiey analysed the reactions of the various participants. Most of the difficulties encountered were related to the technological modifications required in the plant to install the robot and its peripheral equipment, and the labour and organizational changes which affected those most directly involved. TTiis experience provides some general lessons about the dos and do nots of rohotization (see also Besson [3] and Guest [4]). 

On December 3, 1984, a toxic gas release from a pesticide plant in India killed nearly 3000 people and injured at least 100,000 others. The chemical that leaked was methyl isocyanate, a chemical intermediate that was supposed to be stored in a cooled bunker near the plant s outer boundary. The vapor is highly toxic and causes cellular asphyxiation and rapid death. Despite engineering and procedural provisions to prevent its release, a total system breakdown resulted in the release of 40 tons of the deadly material into the densely populated community of Bhopal. Because of this incident, the plant was dismantled and ultimately the parent corporation. Union Carbide, was forced to make a number of organizational changes. The occurrence is considered by many to have been the most tragic chemical accident in history. 

Cockburn, Iain M., Rebecca Henderson, and Scott Stern. 1999. The Diffusion of Science Driven Drug Discovery, Organizational Change in Pharmaceutical Research. National Bureau of Economic Research Working Paper 7359. 

One of the more recent organizational changes within pharmaceutical companies is the formal incorporation of CSR activities into the culture and managerial structures and processes of the firm. This formalization involves consolidating disparate activities into both corporate and affiliate management structures that will be objective-driven, transparent to employees, and complied with consistently across the corporations divisions. Operationalization is a deliberate, multi-year plan, and progress is measured according to achievements of specific objectives. 

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