Safety management system integrity-based approach

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... 

Logic trees are committee-based investigation toois that use a muitipie cause, system-oriented approach to determine root causes integrated with process safety management program. Exampies fauit tree, event tree, causai tree, and why tree. 

It has been demonstrated, that mass deployment of networked, dependable embedded systems with critical control functions require a new, holistic system view on safety critical and security critical systems. Both communities have to interact, communicate and integrate at the end. A unified approach to address the safety AND security requirements of safety related systems is proposed, based on the functional safety standard IEC 61508 and IT-Security management standards, handbooks and guidelines. 

Before moving from discipline-specific standards to a review process that focuses on a multidisciplinary and systems-based approach to care, medication standards were in department-specific chapters, such as pharmacy, nursing, and medical staff, with the latter centered arormd the Pharmacy and Therapeutics committee, the formulary and adverse drug reaction reporting. Over time, the pharmacy standard disappeared and was integrated into the overall patient care chapters. For the 2004 standards, the JCAHO has published a new chapter entitled Medication Management, which reflects increased focus on medication systems and safety. This chapter divides the medication process into six segments ... 

ABSTRACT In most cases, Model Based Safety Analysis (MBSA) of critical systems focuses only on the process and not on the control system of this process. For instance, to assess the dependability attributes of power plants, only a model (Fault Tree, Markov chain. ..) of the physical components of the plant (pumps, steam generator, turbine, alternator. ..) is used. In this paper, we claim that for repairable and/or phased-mission systems, not only the process but the whole closed-loop system Proc-ess/Control must be considered to perform a relevant MBSA. Indeed, a part of the control functions aims to handle the dynamical mechanisms that change the mission phase as well as manage repairs and redundancies in the process. Therefore, the achievement of these mechanisms depends on the functional/dysfunctional status of the control components, on which these functions are implemented. A qualitative or quantitative analysis method which considers both the process and the control provides consequently more realistic results by integrating the failures of the control components that may lead to the non-achievement of these mechanisms. This claim is exemplified on an industrial study case issued from a power plant. The system is modeled by a BDMP (Boolean logic Driven Markov Process), assuming first that the control components are faultless, i.e. only the faults in the process are considered, and afterwards that they may fail. The minimal cut sequences of the system are computed in both cases. The comparison of these two sets of minimal cut sequences shows the benefit of the second approach. 

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