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pt58 replied to the topic Risk analysis in real company in the forum Risk Analysis for Medical Devices 8 years, 4 months ago
In the position I am currently in I do a lot of Risk Analysis. This usually stems from investigations that open up when we are faced with a high failure rate for a particular non-conforming component. When doing the investigation there are several methods one can use to get to the root cause of the problem. This can include several different methods like the five whys, fishbone diagram analysis, ect. Once the root cause(s) is identified they must be addressed. In my company it is policy to use quality system documents to address these. We mainly look at the product Risk Management Summary, Process Failure Mode Effects Analysis, and Design Failure Mode and Effect Analysis. These documents will usually identify all the possible related risks/failures and how they are mitigated. They use a rating system to identify the level of risk. This helps in closing the investigation and will point us in the direction of what type of corrective or preventative actions need to be taken.