![]() ![]() The store should take the form of a water floodable, vented box and have the required service connections to flood and drain built into the structure. The temperature within the storage space and of the packs within must be continuously monitored and connected to an alarm system the use of thermal imaging is recommended in both store and test cell for the early discovery of “hot-cells.” The storage capacity of individual and physically separate storage units should be limited to a size that only requires limited, if any, human entry (machine accessible racks). Storage units should be physically separate from the test laboratory building. ![]() The storage of batteries delivered to the test department needs to follow the same risk management policy adopted for any bulk fuel or energy storage: Finally, there would be an organization risk register held by the board. There can be different levels of risk register, for example, in a hospital the ward or department would hold a risk register, and risks that cannot be managed at this level would sit on a higher level risk register at the directorate or division. Typically this will comprise a risk matrix to grade the consequences and likelihood and then the recording of risks, traditionally by means of a risk register. The policy must set out the process, methods, and tools used to manage the risks within the organization. There needs to be in place a regular review process whereby each risk is reviewed to ensure that the control measures are effective and that the residual risk is correctly graded. The risk owner is responsible for the identification of the hazard, the evaluation and grading of the risk, and subsequent control measures. It is usual for each risk to have a named risk owner. The policy must also clearly define the roles and responsibilities for managing risks often in large organizations there is a risk manager who oversees the risk management framework and processes. The organization’s risk appetite must be clearly articulated in the policy and this may be informed by legal and financial aspects. For organizations involved in medical devices, whether that be manufacturing or in use, one of the key objectives must be patient safety. To ensure risk management is core to the business it must link in to other policies and the objectives of the organization. Like all policies the risk management policy must be subject to periodic review. Anthony Scott Brown, in Clinical Engineering, 2014 Risk Management Policy ![]()
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