Point #4 – Risk Management is not a lifecycle process is one of the most common errors that occurs for most companies when they assess risk management. Risk management is done at the beginning stages of product development and theoretically should be updated accordingly and periodically as the product moves toward complete development. From my experience, I have noticed once a product is launched there are sometimes potential complaints from customers. Those complaints lead to CAPAs or multiple Change Orders to address the issue. One of the issues may potentially be changing the product such as the material. ALL risk management files would need to be addressed and updated if a material change, for example, were to occur. What I have noticed is that companies tend to just make the change and completely neglect the risk management and assume that the risk stays the same. Even if it does the company still needs to document it. When the company is audited this is a serious violation because Quality/Regulatory is failing to document a change that directly makes contact with a customer. I’ve seen Warning Letters issued because of this.