Design, organizational

A written validation protocol should be established that specifies how process validation will be conducted. The protocol should be reviewed and approved the quality control unit and other designated organizational units. 

Designing organizational structures that encourage healthy and safe working behavior... 

Our goal in this chapter is to share our conceptualization of inclusive climates as well as our thoughts on how one might design organizational change efforts for enhancing inclusion. Our focus is on the inclusiveness of work environments, with the assumption that people experience more personal inclusion when they work in an inclusive climate. 

Organizational and plant design policies, directed by senior management plant and corporate management, and implemented by line management affect conditions that influence error. 

The standard requires that organizational interfaces between different groups which input to the design process be identified and the necessary information documented. 

How do you identify, document, transmit, and regularly review the organizational and technical interfaces between different design groups ... 

A statement of work which you require the subcontractor to perform - it might be design, development, management, or verification work and will include a list of required deliverables such as project plans, quality plans, production plans, drawings, test data, etc. You need to be clear as to the interfaces both organizationally and technically (see Part 2 Chapter 4). 

In the organizational sense, a function is a special or major activity (often unique in the organization) which is needed in order for the organization to fulfill its purpose and mission. Examples of functions are design, procurement, personnel, manufacture, marketing, maintenance, etc. 

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. 

At this point in the process, you may find it useful to review the preliminary plan you presented for initial management approval (see Chapter2). That "first take" necessarily lacked the detail you are now able to provide. For example, your initial estimates of time requirements might have predicted 18 months for system design and installation now you reali2e that 24 months will be needed. While the initial plan will require changes, it should have components (organizational, stylistic, narrative) that can be adapted for use in the formal plan. 

This section illustrates some of the more global influences at the organizational level which create the preconditions for error. Inadequate policies in areas such as the design of the human-machine interface, procedures, training, and the organization of work will also have contributed implicitly to many of the other human errors considered in this chapter. 

Management and Policy Influences on Error and Accident Causation As has been emphasized in Chapters 1,2, and 3, the system-induced error view states that it is insufficient to consider only the direct causes of errors. The underlying organizational influences also need to be taken into accoimt. However, most of the available techniques stop when an immediate cause has been identified, such as less than adequate procedures or poor equipment design. The questions of why the procedures were poor, or why the equipment was badly designed, are rarely addressed at the level of policy. Kletz (1994a)... 

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