Standards organizational aspects

This chapter examines varions validation strategies that can be adopted around organizational roles, outsourcing, standardizing computer apphcations and software reuse, segregating GxP aspects of integrated systems, retrospective validation of legacy systems, and use of statistical techniques to support validation. 

Shein divides culture into three levels (figure 13.2) [188]. At the top are the surface-level cultural artifacts or routine aspects of everyday practice including hazard analyses and control algorithms and procedures. The second, middle level is the stated organizational rules, values, and practices that are used to create the top-level artifacts, such as safety policy, standards, and guidelines. At the lowest level is the often invisible but pervasive underlying deep cultural operating assumptions... 

The metric of audit scores is a proactive measurement of safety performance. Audits are used to measure the safety performance of a school against established organizational standards or government regulations. Questions are asked related to each aspect of a safety program being audited. The responses to these questions on the audit are then translated into a score that can serve as the metric that is used to measure performance. Types of safety audits cau include ... 

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