Risk controls defined

SALE SYSTEM OF WORK A foiTual pt ocedufe resulting from systematic examination of a task to identify all the hazards. Defines safe methods to ensure that hazards are eliminated or risks controlled. 

Event— An occurrence involving the process caused by equipment performance, human action, or by an occurrence external to the risk control system. In Multilinear Event Sequencing (MES) an event is defined as one actor plus one action. 

Models of radiation damage have been explored and are well developed. For many years, accidental releases of ionizing radiation have been universally feared. Alternatively, radiation has been used in controlled, defined amoimts as a therapy for certain tumors in both companion animals and humans. Taken together, all studies provide a cohesive and comprehensive picture of radiation toxicity. There are sufficient details of radiation effects to make credible estimates of risk resulting from radiation exposure (Harley 2001, 2008). 

ICH Q9 defines the principles by which risk management will be integrated into decisions regarding quality and CGMP compliance. Q9 focuses on important aspects of this risk management, risk control, communication, and review. It also speaks to the emerging trend of much closer collaboration between the regulators and the industry (see Reference 6 for an excellent overview). 

Awareness of the risk in the controlled process is a major component of safety-related decision making by controllers. The problem is that risk, when defined as the severity of a loss event combined with its likelihood, is not calculable or knowable. It can only be estimated from a set of variables, some of which may be unknown, or the information to evaluate hkelihood of these variables may be lacking or incorrect. But decisions need to be made based on this unknowable property. 

When it comes to public safety, the way judgments about risks are framed are arguably even more important. Do we for instance define risk in terms of loss of hfe, material damage, or their perceived severity When risks are defined in terms of loss of hfe, it could have considerable consequences whether loss of hfe is defined as a total number of hfe years lost or as a number of deaths. As Slovic (1999) put it Whoever controls the defirution of risk controls the rational solution to the problem at hand . The AS/NZS 4360 Risk Management Standard acknowledges this issue by providing only examples of quantitative risk expressions, such as the average individual probabhity of death in an exposed population and the number of new ill-health cases per annum in an exposed population. 

There are many definitions for risk. Rowe defines risk as the potential for realization of unwanted, negative consequences of an event. Risk aversion is action taken to control or reduce risk. 

The best-known measure for safety is risk. Risk is defined as the potential for loss or the probability of a specified undesired event s occurring in a particular period of time and its consequences. An inherently safe chemical process is one that avoids hazards instead of controlling them. Heikkila (1999) developed a method for... 

Residual risk Risk can never be eliminated entirely, though it can be substantially reduced through application of the hierarchy of controls. Residual risk is defined as the remaining risk after controls have been implemented. It is the organization s responsibility to determine whether the residual risk is acceptable for each task and associated hazard. Where the residual risk is not acceptable, further actions must be taken to reduce risk. 

A major premise to be considered in applying a hierarchy of controls is that the outcome of the actions taken is to be an acceptable risk level, defined as follows ... 

These information sources can be used independently or in combination. Direct observation includes inspection activities and the monitoring of the work environment (e.g. temperature, dust levels, solvent levels, noise levels) and people s behaviour. Each risk control system should have a built-in monitoring element that will define the frequency of monitoring these can be combined to form a common inspection system. 

Safety culture is the attitudes, beliefs and perceptions shared by natural groups as defining norms and values, which determine how they act and react in relation to risks and risk control systems. 

Refer to Chapter 9, Risk Perception— Defining How to Identify Personal Responsibility , and Chapter 10, Risk Management Principles , for a detailed discussion on a method to help identify risk perception and controlling risk. 

Employees are in close contact with real and/or potential hazards and associated risks every day. However, they may have developed their own way of doing the job more efficiently that may or may not be adequately controlling the hazards and associated risks. Refer to Chapter 9, Risk Perception—Defining How to Identify Personal Responsibility . 

A concept that is internationally used for risk management decision-making is defined as low as reasonably practicable risk . Once the risk of the operation or item in question has been assessed, a determination must be made of how effective any controls are that are put in place. Acceptable risk is defined as that risk for which the probabiUty of a hazard-related incident or exposure occurring and severity of harm or damage that may result are as low as... 

The choice of what is appropriate will depend on many factors and the search is to find which level, or which mix, provides the best way of defining and measuring risk control. What are the boundary markers we can most unambiguously define to indicate that the system is moving outside the envelope of control and needs corrective or punitive action ... 

Ethically and legally, it is expected that the risk of any undertaking is mitigated/controlled to an acceptable level. In the UK in particular, the acceptable level of risk is defined as ALARP. This requirement calls for the identification of the controls of hazards on an individual basis (for each hazard) including consideration of all possible controls. It is only when there is nothing else practicable that can be done to reduce the risk level further, that the safety risk emerging from the system can be considered as ALARP. 

These requirements define the activities of a designer, manufacturer, and user of a machine, which include performing all the procedures within the risk control systems. This is based on the principle of application of the causal relation of accident or failure occurrence as a part of the risk control systems at all the stages of a machine s technological lifespan. 

PreUminary risk analysis defines the Equipment Under Control (EUC), its limits, its environment, all modes of operation, the dangers and risks associated with the equipment and its control system. An inventory of risk is established and the risks that are covered by the system are confirmed. In our case, it was initially decided... 

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