Organizational structure, management

As a result of the diverse nature of the industry, their hazards, and organizational structure, management attitudes toward a safety prc am and government emphasis on accident prevention have created a wide diversity of safety positions, duties, and responsibilities in industrial plants. 

The elements of the system can be construed to be the 20 elements of ISO 9001. The components of the system are different. ISO 8402 states that a quality system is the organizational structure, procedures, processes, and resources for implementing quality management. It therefore follows that in reviewing the quality system one needs to review each of these aspects. 

This sample is designed to summarize the key steps in the process a centralized company or division plans to follow in developing PSM. Note that the primary difterences indicated relate to reporting requirements and timeframe the process components remain the same regardless of organizational structure or management style. 

Management style or philosophy Organizational structure or reporting relationships Company and union relationship Shift regimes... 

An organizational structure is established for the project which is consistent with other quality management projects. 

Contrary to Quality Management principles, the process is following organizational structures. 

Factors that influence this include the degree of decentralization to individual divisions or facilities and whether there are significant differences in organizational structure and business management processes between divisions and facilities. 

Management processes tend to follow the organizational structure... 

A quality system comprises the organizational structure, responsibilities, procedures, processes, and resources used to implement quality management, or ESH/PSM management in this case. This part of the standard includes a somewhat detailed discussion of each of the parts of the quality system as well as its documentation. 

Audits may differ. Some concentrate on particular facets, e.g. waste minimization, energy conservation. A management audit will probably cover organizational structures and relationships, communications, procedures acceptance and implementation, training and quality assurance. A technical audit will consider the performance of plant and equipment, monitoring and inspection programmes. Items for inclusion in auditing are listed in Table 17.12. 

Somewhat different organizational structures may be needed for managing different kinds of chemical reactivity hazards. As defined in Section 1.3, three general situations involving chemical reactivity hazards are as follows ... 

A safety management system for implementing the prevention policy has been put into effect. The policy should include the organizational structure, responsibilities, practices, procedures, processes, and resources for determining and implementing the policy. 

Environment and Management = Organizational Structure in ADME/Tox Screening 19... 

In management science, use of rugged landscape models has been brought to bear on questions concerning the adaptability of organizations, optimal organizational structure, the co-evolution of organizations, and further topics. 

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. 

There should be an appropriate and sufficient structured system, including organizational structure and documentation infrastructure, sufficient sufficient personnel and financial resources to perform validation tasks in a timely manner. Management and the personnel responsible for quality assurance should be involved in this discussion. Validation performance must be under the responsibility of appropriate and experience personnel that should represent different departments depending on the validation work to be performed. 

Within firms, the hybrid or matrix concept has become increasingly fashionable in pharmaceutical companies. Project teams are created that comprise membership from departments with specific technical, organizational, and management expertise. Such teams form and dissolve as the need arises. In principle, advantages of the matrix structure include cross-disciplinary enrichment of the team s activities and crossfertilization of expertise. Disadvantages of the matrix system include a relative lack of professional development for specific technical expertise for each team member, the potential for cross-departmental rivalry, and competition for each team member s time based on the needs of the interdisciplinary project versus those of his/her technical "home" department (Verona and Ravasi 2003). These multi-functional teams have the potential to increase bureaucracy and delay innovation. At least on a small scale, it may be better to solve a problem with two people rather than with ten. 

The organizational structure, responsibilities, procedures, processes, and resources for implementing quality management comprise the quality system. 

An organizational structure should be established to facilitate the qualification of computer systems operating in the GMP environment. The organization should be representative of the departments involved, and would typically include quality management, owner/user department, information technology, and engineering. 

The kind of effort expended for PV is largely determined by organizational structure. Whether PV is managed by a department, a consultant, or a committee, the criteria for the program are still the same. These criteria will be examined by the responsible individuals so that the program will be tailored to the character of the process under study. The following questions are recommended in developing a suitable validation protocol or plan. 

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