Risk management principles

The PAT framework and ICH Q8 will provide a basis for risk mitigation. Risk management principles and tools being developed under ICH Q9 will be necessary to describe and communicate the level of risk-mitigation achieved through quality by design and process understanding. 

Precaution and Environmental Science. When the precautionary principle is discussed in its relationship to science, it is often portrayed as an antiscience or a risk-management principle that is only used after undergoing conventional scientific processes. As discussed earlier, in practice the limitations of science to characterize complex risks show that precaution is not at odds (Kriebel et al., 2001). Further, precaution is not just about additional safety factors or changing risk assessment default assumptions. Research by U.S. EPA scientists has demonstrated that many of the EPA s Reference Doses - or conservative safe exposures - may correspond to risks of greater than 1 in 1000, meaning that safety factors alone may not protect health (Castorina and Woodruff, 2003). 

An approach to dealing with the threat focused on mission success and based on risk management principles, as opposed to the prevailing (and largely unachievable) philosophy of avoiding contamination ... 

United States Environmental Protection Agency (USEPA), Ecological Risk Assessment and Risk Management Principles for Superfund Sites, U.S. Environmental Protection Agency, Washington, DC, 1999, http //www.epa.gov/fedfac/documents/eco risk superfund. htm (accessed August 2008). 

International Organization for Standardization. ISO 31000 2009, Risk management -Principles and guidelines. 2009. 

SUBSAFE is founded on a basic set of risk management principles, both technical and cultural. These fundamentals are ... 

Whilst most Robens-style OHS legislation makes some reference to the manufac-tirrer s duty of care in providing a safe product, there is also a duty of care for organizations to eliminate hazards where practicable. The apphcation of risk management principles to the pitrchase of new products is one method to hmit the introduction of new hazards into the organizatioa... 

ISO/IEC 31000 2009. Risk Management—Principles arul Guidelines, and ISO/ lEC 31010 2009. Risk Assessment Techniques. 

ANSEASSE Z690.2— 2011. Risk Management Principles and Guidelines (National Adoption of ISO 31,000 2009). The intent of this standard is to provide a broad ranged primer on risk management systems that could be applied in any type of organization. The need to make risk assessments is introduced in 5.4 Risk Assessment. 

ANSI/ASSE Z690.2—2011. Risk Management Principles and Guidelines. Des Plaines, IL American Society of Safety Engineers, 2011. 

ANSI/ASSE Z690.2-2011 (Risk Management - Principles and Guidelines) and its companion standards, Vocabulary for Risk Management and Risk Assessment Techniques, were approved earlier this year. The ANSI Z690 standards are an identical national adoption to the ISO risk management standards e.g. 31000 finalized in 2009. 

Although the risk management standards are available for purchase from ISO, ANSI, ASSE and other sources, there is a free way to get a look at the general language in the standards. Run a Google search for < ISO 31000 draft download>. The search will provide the draft to the ISO Risk Management - Principles and... 

If your organization does not practice formal risk management, there may be no risk owner who is the person or entity with the accountability and authority to manage risk. If this is the case, then you should initiate the process. Eventually, all EHS pros may need a working knowledge of modem risk management principles. 

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. 

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