<Li> see concerns about schedule variance as this is a function of it, as illustrated in the equation above . </Li> <P> Risk in a project or process can be due either to Special Cause Variation or Common Cause Variation and requires appropriate treatment . That is to re-iterate the concern about extremal cases not being equivalent in the list immediately above . </P> <P> For medical devices, risk management is a process for identifying, evaluating and mitigating risks associated with harm to people and damage to property or the environment . Risk management is an integral part of medical device design and development, production processes and evaluation of field experience, and is applicable to all types of medical devices . The evidence of its application is required by most regulatory bodies such as the US FDA . The management of risks for medical devices is described by the International Organization for Standardization (ISO) in ISO 14971: 2007, Medical Devices--The application of risk management to medical devices, a product safety standard . The standard provides a process framework and associated requirements for management responsibilities, risk analysis and evaluation, risk controls and lifecycle risk management . </P> <P> The European version of the risk management standard was updated in 2009 and again in 2012 to refer to the Medical Devices Directive (MDD) and Active Implantable Medical Device Directive (AIMDD) revision in 2007, as well as the In Vitro Medical Device Directive (IVDD). The requirements of EN 14971: 2012 are nearly identical to ISO 14971: 2007 . The differences include three "(informative)" Z Annexes that refer to the new MDD, AIMDD, and IVDD . These annexes indicate content deviations that include the requirement for risks to be reduced as far as possible, and the requirement that risks be mitigated by design and not by labeling on the medical device (i.e., labeling can no longer be used to mitigate risk). </P>

Which of the following is not an element of the disaster risk decision tree​ model