Management risk control processes

Many would say that in the last 10 years a cultural revolution has occurred in healthcare delivery. Organisations in many countries are now more aware than ever of the potential for healthcare to cause harm. In response, most healthcare organisations have put in place measures to identify, report and manage adverse incidents and near-misses along with proactive risk control processes. The challenge for managers of these organisations is to extend this cultural awareness into the implementation of... 

Inclusion of the implantation and follow-up phases of the product life cycle in the risk control process. This would require safety management systems, which are in general not yet available in the medical device industry and health care. 

The theory and application of systematic risk assessment is a part of effective risk control processes. Methods for risk assessment or estimation allow the quantification of the risks and, thus, provide top managers with relevant information for risk reduction within the Man-Machine-Environment system. The following theses form the basis for the risk assessment methods selection (see also Chapter 1) ... 

Accountability is the obligation to answer for one s performance with respect to expectations, goals, and objectives. It is an important element of an effective process safety management system. To improve safety, the risk associated with human errors must be reduced. The work situation is the predominant cause of human errors and management has control over the work situation. 

Risk management is a continuous process as was highlighted in Chapter 5, the consequences and frequency of an event are highly condition dependent. As a result, managing risk requires that conditions that may increase event severity or likelihood are adequately controlled. For example, if crane safety programs are not followed, the frequency of occurrence of dropped loads or overturned cranes may increase. This could result in substantially increased risk of piping failure and material release. 

Procedural controls, process controls, 98-99 Process controls, 96-100 active controls, 98 inherently safer approach, 97 mitigation techniques, 99 passive controls, 97-98 procedural controls, 98-99 safe operating limits, 99-100 Process definition, documentation, 102-104 Process design, documentation, 105 Process hazard analysis (PHA) risk assessment, 92-93 screening methods, 63 Process risk management decisions, documentation, 105-106... 

Perhaps more importantly though, remediation under Part IIA and the suitable for use approach is in essence a process of managing and controlling risk in very specific circumstances. In particular, a site that has been made safe in the context of a particular land use may require further remediation if a new, and more sensitive, land use is proposed. It therefore seems entirely appropriate that... 

There is no adequate evidence of environmental components as dominant causes of cancer, but it is likely that tobacco and diet play a very impcMiant role [4]. Howevo-, there is little activity in investigating complex environmental conditions and toxicological studies involving natural ecosystems as part of a process of risk management and control. 

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