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FSMA-compliant Hazard Analyses address radiological hazards in addition to the chemical, biological and physical hazards covered by HACCP systems. [16] FSMA explicitly requires a Food Defense component, with both terrorism and Economically Motivated Adulteration addressed. Businesses with less than $10,000,000 a year in sales are exempt.
ORM is the oversight of operational risk, including the risk of loss resulting from inadequate or failed internal processes and systems; human factors; or external events. Unlike other type of risks (market risk, credit risk, etc.) operational risk had rarely been considered strategically significant by senior management.
When used as part of an aviation hazard analysis, a "Likelihood" is a specific probability. It is the joint probability of a hazard occurring, that hazard causing or contributing to an aircraft accident or incident, and the resulting degree of loss or harm falling within one of the defined severity categories.
The outcome is the harm that results from an uncontrolled hazard. A risk is a combination of the probability that a particular outcome may occur and the severity of the harm involved. [108] "Hazard", "risk", and "outcome" are used in other fields to describe e.g., environmental damage or damage to equipment.
The risk rating of the hazard prior to applying the control is known as the 'inherent risk rating'. The risk rating of the hazard with the control in place is known as the 'residual' risk rating. Risk, within the occupational health and safety sphere, is defined as the 'effect of uncertainties on objectives [ 8 ] '.
The COSO "Enterprise Risk Management-Integrated Framework" published in 2004 (New edition COSO ERM 2017 is not Mentioned and the 2004 version is outdated) defines ERM as a "…process, effected by an entity's board of directors, management, and other personnel, applied in strategy setting and across the enterprise, designed to identify ...
A good risk management plan should contain a schedule for control implementation and responsible persons for those actions. There are four basic steps of risk management plan, which are threat assessment, vulnerability assessment, impact assessment and risk mitigation strategy development. [33]
In addition, the differences between individuals due to genetics or other factors mean that the hazard may be higher for particular groups, called susceptible populations. An alternative to dose-response estimation is to determine a concentration unlikely to yield observable effects, that is, a no effect concentration .