Producers’ risk

Rejected Error of first kind producer risk false alarm Test result OK... 

NaHCOs and CaCOs can neutralize HCl rapidly, depending on particle size and crystal structure, and effectively. NaHCOs acts rapidly but absorption of unneutralized NaHCOs produces risks for alkalosis and sodium retention which may lead to edema, hypertension or heart failure. Also neutralized antacids may cause alkalosis by permitting the absorption of endogenous NaHCOs. Ca + may stimulate the secretion of gastrin and HCl and calcium-containing antacids have been associated with rebound acid hypersecretion. 

The National Center for Environmental Assessment (NCEA), which is part of the EPA Office of Research and Development (ORD), serves as the national resource center for the overall process of human health and ecological risk assessments the integration of hazard, dose-response, and exposure data and models to produce risk characterizations. NCEA prepares a variety of documents, many of which are the source of scientific information used by EPA decision makers in developing or revising regulations. The documents can pertain to a specific medium, such as air or water, or they can be comprehensive analyses of scientific data. Many NCEA documents contain analyses... 

It is important to note that measurement of one analyte, API or metabolite, carries the risk of making a type-I error (the consumer risk) to remain at the 5% level. However, if more than one of several analytes is selected retrospectively as the bioequivalence determinant, then both the consumer and producer risks change (7). 

EPA is naturally interested in producing risk assessments of the highest possible quality. This requires that each assessment is sensitive to site-specific conditions, while using procedures that are consistent with those of other agency-sponsored assessments. Both inconsistency in approach and lack of technical quality (such as insensitivity to local conditions) represent problems in the risk assessment process. EPA is actively engaged in several efforts to maintain quality and consistency in risk assessment, in the face of distinctly limited professional resources. 

There are two types of risks when making this decision the consumer perspective [26], that is, the risk of validating/accepting an invalid method, and the producer perspective, that is, the risk of invalidating/failing a valid method. The consumer risk is typically more important to control as this can impact the selection of an appropriate dose for the patients or disease diagnoses based on a biomarker depending on the context. The producer risk results in extra cost to the sponsor due to the additional development and optimization that may be necessary if the method is declared invalid. 

However, if the analytical bias is relatively high, but the method is truly valid (borderline situation), the producer risk can be quite high. Use of a larger sample size will not reduce this risk. 

Hazards encompass any aspect of technology or activity that produces risk (Fischhoff, p. 217). 

In the term hazards-related, it must be understood that hazards are to include any aspect of technology or activity that produces risk (Fis-chhoff, p. 217). A hazard is defined as the potential source of harm... 

All of the incidents to which this causation model applies derive from hazards. There are no exceptions. Hazards include aU aspects of technology and activity that produce risk. 

By definition, all risk controversies concern the risks associated with some hazard. .. the term hazard is used to describe any activity or technology that produces risk [p. 217]. 

Hazards must be considered in the broad context of that definition. Every element within the safety management process should serve to avoid, eliminate, or control the aspects of personal activity or inactivity and the aspects of technology that present a potential for harm or damage and produce risk. 

Behavior-based safety is based on one of the oldest and most outdated approaches to safety — the Heinrich premise that 88% of all industrial accidents are caused primarily by unsafe acts of persons [p. 1]. Behavior-based safety does not focus on what really causes accidents. Injuries and illnesses are caused by exposures to hazards. What do I mean by hazards Hazards include any aspect of technology or activity that produces risk. If the work methods designed and prescribed put employees at risk, those methods are hazardous [p. 5]. 

A hazard is defined, broadly, as the potential for harm to people, property, or the environment. If there is no potential for harm, injury or damage cannot occur. (In ZIO, a hazard is defined as a condition, set of circumstances, or inherent property that can cause injury, illness, or death.) The dual nature of hazards must be understood. Hazards encompass all aspects of technology or activity that produce risk. Hazards include the characteristics of things (equipment, dusts, etc.) and the actions or inactions of people. 

Identify the Hazards. A frame of thinking should be adopted that gets to the bases of causal factors, which are hazards. These questions should be asked What are the aspects of technology or activity that produce risk What are the characteristics of things or the actions or inactions of people that present the potential for harm. Depending on the complexity of the hazardous situation, some or all of the following may apply ... 

Combustible, dust may produce risk of explosion with air. 

A hazard is defined as the potential for harm. Hazards include all aspects of technology and activity that produce risk. Hazards are the generic base of, as well as the justification for the existence of, the practice of safety. If there were no hazards—no potential for harm— safety professionals need not exist. The entirety of purpose of those responsible for safety, regardless of their titles, is to manage with respect to hazards so that the risks deriving from the hazards are acceptable. 

One can also view the lead picture as being an excellent model for integrated risk assessment across the dose spectrum for substances that not only produce risk of toxic harm but have been shown to actually cause disease. Integrating risk for a global contaminant and toxicant like lead can also be considered with respect to those risks and associated risk populations that exist across population and system boundaries. This includes ecological risk assessment as well as human risk assessments from the standpoint of how the outcomes of the former affect the latter and vice versa. 

At the most obvious level, risk specialists can help rhetoricians elicit what audiences know and how they structure their understanding of complex issues. They can also help rhetoricians think more systematically about the material processes that produce risk and hazard in the workplace. Morgan et al. (2002) write ... 

In order to devise a safety culture and program that will actually work to protect chemical workers, we first must determine where the injuries and illnesses come from. Chemical hazards include any aspect of technology or activity that produces risk. The level of risk is primarily the combination of two factors the level of toxicity present and the degree of exposure. The level of toxicity is reduced by substitution of materials and design. Exposure is most effectively reduced through the use of engineering controls such as safety devices, enclosures, guards, and ventilation systems. 

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