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jlw23 replied to the topic Risk Identification in the forum Risk Analysis for Medical Devices 7 years, 4 months ago
There are many ways risk are identified and dealt with in a company. In every department there are different risk factors that are considered for different perspective and that are sometimes only applicable to their department. In my experience risk is defined in process development and in manufacturing is managed when deviations occur. Because I work in process development a lot of out risk management go into making sure the process for the product is risk free. We manage risk by using batch records that spell out the process and must be followed and verified by another operator.