Organisations providing safety information

In conclusion, proactive safety indicators either irtfluence safety management priorities and the chosen actions for safety improvement or provide information about the dynamics of the sociotechnical system (not merely about the functioning of safety barriers and absence of harm). These proactive indicators are respectively labelled drive indicators and monitor indicators in this chapter. Safety indicators should be capable of measirring (morritor indicators) or facilitating (drive indicators) the presence of organisational attribrrtes necessary for ensuring adequate patient safety. 

Using incidence and frequency rates enable sensible trend analyses to be carried out during periods when changes are being made in the organisation that affect the number employed or the amount of work being done and, used properly, they can provide useful safety information. 

As can be seen from the preceding section all organisations are required to provide safety information in relation to the products and services that they manufacture, produce or provide. Information can therefore be gleaned from manufacturers documentation and records, e.g. sound levels, chemical hazards, weights of items and flammability ranges. 

It is necessary for safety information to be communicated to external bodies. For example, certain specified work-related injuries, diseases and dangerous occurrences must be notified to the enforcers as soon as practicable after they occur (see Chapter 12). Other information relating to the safety performance of an organisation will need to be provided to insurance companies and potential customers. In the public services, information has to be provided to governing bodies or other government agencies responsible for monitoring public sector performance. 

One of the most fundamental challenges that faces investigators when dealing with large quantities of relatively minor incidents is how to identify and assess the risk of what is reported, and so properly focus attention, prioritise action and allocate resources within the organisation. In practice, the primary tool provided for this purpose in most safety information systems is a risk profile matrix, risk table or risk map. These are simplistic tables... 

The ICH have issued guidelines on how to organise the data in the modules. These guidance documents, which are shown in Table 6.3, deal primarily with how the information should be organised, whereas advice on how to generate the data is provided in the quality, safety and efficacy guidelines that were discussed in the previous chapters. We shall now look at the stmcture of the modules in a little more detail, starting with the basic data modules. 

The Occupational Safety and Health Organisation (OSHA, www.osha.gov), the National Institute of Occupational Safety (NIOSH, www.cdc.gov/niosh) and the American Conference of Governmental Industrial Hygienists (ACGIH) are the three main agencies that provide information on safe exposure limits for airborne contaminants, developed mainly for workers. 

Fig. 11.1 provides a simple illustration of the role the Design Organisation plays in through life safety of their type-certificated products. The following subsections will explore some of these interfaces and how the flow of hazard information finds its way into the ICA. 

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