Risk management considered

There are also opportunities for making active and procedural risk management systems inherently safer. For example, consider two alternative designs for a high pressure interlock for a vessel ... 

We consider ESH risk management to be part of the normal conduct of our business, and we will seek to identify and manage risk wherever it occurs. 

In instances where cover is written on this basis, it is normal that higher than usual excess is applied, reflecting the type of plant involved. While it is normal on the more traditional basis for the insurance cover to be complementary by inspection of the insured items in the case of covers written in this manner, it is usual for the inspection of all statutory plant to be incorporated together with those items where the insurer considers inspection to be necessary as part of the risk management of the cover being provided. 

In this phase of the risk assessment, the validity and reliability of conclusions and advice to risk managers depend on the quality, reliability, and relevance of available exposure data. Therefore it is necessary to (1) critically review the facts from food composition tables and the reasons for differences reported by and within countries, (2) consider the way foods are categorized and thus made comparable (or not) in food consumption surveys, and (3) explore how to refine assessments as more information becomes available. ... 

Therefore, risk management utilizing protective clothing should be considered carefully, as estimation of the reduction of external exposure using protective clothing may overestimate the protective potential. 

Accepted risk The risk is considered tolerable for a given activity by those responsible for managing or regulating the operation of a hazardous facility. The term acceptable risk has often been used, but this inevitably raises the question, Acceptable to whom Tweeddale... 

Where a consortium may exist, the economic interest of the partners must be considered and their management must approve of the risk involved in the venture. Where such risks are considered unacceptable by the partners their interest must be protected to their satisfaction. 

Risk management measures can be separated into genuine risk management measures and ingenuine, auxiliary, risk management measures. While only the former should be considered seriously, the latter is reviewed briefly lest a responsible marketer or public policy official finds himself or herself leaning in ill-advised directions. 

In making risk management decisions it is important to take into account nontechnical factors in addition to scientific and economic information. Recent crises in the food industry have indicated that consumers perceptions about risks are driven by factors that would not be considered in conventional risk assessments. Research has shown that factors such as whether sub-groups (particularly children) might be affected, whether the hazard is familiar, if there are effects on the environment or if risks and benefits are equitably shared can determine consumers reactions to an issue. 

It is widely understood within the industry that risk is defined as the combination of the probability of harm and the severity of that harm. Within the pharmaceutical industry whenever risk is considered the equipment or product being assessed must be viewed in the context of the protection of the patient. From our perspective, analytical instruments may impact on the validity of data that determines the safety and efficacy of drug products, or on the quality of the drug product. They may also impact on the identity or potency of the drug product and therefore it is important to ensure that risk management is performed throughout the complete life cycle of the instrument. 

Since fires are frequently identified as the dominant type of loss event in many process facilities, the fire prevention program should be considered an essential part of a Risk Management System. Fire prevention often includes procedures and features to support other types of emergency management and loss prevention efforts. 

Since traditionally pharmaceuticals have not been considered as environmental contaminants, the study of their presence in the environment is in some ways a new area of research which has taken off recently. Nonetheless, so far, there is little knowledge on their occurrence, fate and environmental assessment, an essential tool for the implementation of minimizing measures and risk management. Potential risks associated with releases of pharmaceuticals into the environment have become an increasingly important issue for pharmaceutical industry and environmental regulators [7, 11]. 

Risk management The substitution of a hazardous substance contained in a product or a process by a less hazardous substance may be an appropriate way of reducing risks. Modified technical systems or methods can, however, also be considered as additional or complementaiy in action. Management systems for developing less hazardous substances and for the secure use of hazardous substances (closed systems, certification of users) are also part of this process. We... 

The selection of an MOE that would be considered acceptable is a societal judgment and primarily the responsibility of risk managers rather than risk assessors. EFSA considered that an overall MOE of 10,000 for the BMDLio, or 25,000 for the T25, would be of low health concern. 

FDA has also formed a Drug Safety and Risk Management Advisory Committee during this time, provided specific training for the members and has subsequently placed selected members on Advisory Committee Panels to consider various risks or to review existing risk management programs. 

Risk management is the process of deciding what to do to reduce a known or suspected risk. Risk management balances the various community demands with the scientific information generated from the risk assessment. Public perception of risk is also considered. Table 19.2 characterizes some of the factors that influence perception of risk. An individual s perception of risk is sometimes very different from a risk... 

If the assessment is to be probabilistic, the risk assessor and risk manager should consider together how this influences the definition of the assessment endpoint. Suter (1998) suggests 5 questions for the risk assessor to ask the risk manager to help define the assessment endpoint ... 

Irrespective of the risk, assumptions and decisions will have to be made because of uncertainty. Implications of attempting to characterize all variability and uncertainty in the risk assessment need to be considered. For example, exaggerating uncertainties can obscure the scientific basis of risk management decisions, leaving the impression that the decision has been arbitrary in nature (NRC 1989). The purpose of the uncertainty factor together with the type of assessment (e.g., deterministic or probabilistic, protective or best estimate) must be clearly communicated. Uncertainty factors can be described in 3 categories ... 

Risk management A decision-making process that considers political, social, economic, and technological information in conjunction with risk assessment information to select an appropriate response to a particular problem. 

One of the main requirements is the verification of the biocompatibility and a risk management, which have to consider the results of a clinical study and post-marketing (vigilance) studies [17]. 

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