Safety management system assessments

The State of California has a Safety Assessment Management System (SAMS) for the control and management of offshore facilities. It falls under the jurisdiction of the California State Lands Commission, and its enforcement relies to a large extent on a cooperative relationship between the state and offshore operators. 

Managing safety related requirements Developing a safety case Managing system change Safety testing and chnical evaluation Monitoring the system in live operation Assessing personnel competency... 

The safety objectives are both a sub-system, but also is an independent factor. The safety objectives are to guide safety production management system and the end result. The main contents include safety objectives system, safety objectives management operation mechanism, the safety objectives system assessment mechanism. 

Jodejko-Pietruczuk, A., Werbinska-Wojdechowska, S. (in press). Expected maintenance costs model for time-delayed technical systems in various reUability structures. Article accepted forpubheation in Proc. of The Probabilistic Safety Assessment Management conference PSAM 12, 22-27 June 2014, Honoltilu, Hawaii, USA. 

The safety case approach makes the system owner/manager responsible for proving that their activities are safe - and continue to remain so. Every system owner/ manager is thus required to undertake a formal assessment of the safety of their facility and develop a report which documented the hazards, safeguards, safety and management systems, and emergency response plans for the system/facility throughout its life cycle. 

Each PSM system can then be examined to determine what system modifications (if any) are needed to address the new issues. For example, the process hazard assessment system might be modified to include participation by industrial hygienists to identify potential sources of exposure. Some process safety management systems (e.g., process documentation) may require no modification to support a wider scope. 

The computerized systems, both hardware and software, that form part of the GLP study should comply with the requirements of the principles of GLP. This relates to the development, validation, operation and maintenance of the system. Validation means that tests have been carried out to demonstrate that the system is fit for its intended purpose. Like any other validation, this will be the use of objective evidence to confirm that the pre-set requirements for the system have been met. There will be a number of different types of computer system, ranging from personal computers and programmable analytical instruments to a laboratory information management system (LIMS). The extent of validation depends on the impact the system has on product quality, safety and record integrity. A risk-based approach can be used to assess the extent of validation required, focusing effort on critical areas. A computerized analytical system in a QC laboratory requires full validation (equipment qualification) with clear boundaries set on its range of operation because this has a high... 

Once past the discovery and initial development stages, the safety assessment aspects of the process become extremely tightly connected with the other aspects of the development of a compound, particularly the clinical aspects. These interconnections are coordinated by project management systems. At many times during the early years of the development process, safety assessment constitutes the rate-limiting step it is, in the language of project management, on the critical path. 

A scientific approach to safety assessment, such as the one presented in this chapter, does have proponents and adherents. Such an approach requires those involved in both the management and conduct of the safety assessment process to continually question (and test) both the efficacy and the validity of their evaluation systems and processes. More to the point, it requires recognition of the fact that we have always done it this way is not a reason for continuing to do so. This approach asks first what is the objective behind the testing, and then it asks how well our testing is meeting this objective. 

---