I think the wording of this Warning Letter may lead to some confusion, Naveen. They use the term "Risk Matrix" here which is commonly identified in most systems as the table that has Severity of Harm on one axis and Probability of Occurrence of Harm on the other. The intersection of a Severity and a Probability is used to establish the risk.
I don't think Risk Matrix in this Warning Letter means that. I believe they are talking about the lack of an entry in the Risk Analysis for the situation encountered by the manufacturer which was not identified in the risk management system. Perhaps the manufacturer used the term in their encounter with the FDA and this is what led to the confusion in terminology.
We always need to make sure we are using the right terms and definitions when we communicate with others so we do send the intended message and it is received with the same meaning.
I think the wording of this Warning Letter may lead to some confusion, Naveen. They use the term "Risk Matrix" here which is commonly identified in most systems as the table that has Severity of Harm on one axis and Probability of Occurrence of Harm on the other. The intersection of a Severity and a Probability is used to establish the risk.
I don't think Risk Matrix in this Warning Letter means that. I believe they are talking about the lack of an entry in the Risk Analysis for the situation encountered by the manufacturer which was not identified in the risk management system. Perhaps the manufacturer used the term in their encounter with the FDA and this is what led to the confusion in terminology.
We always need to make sure we are using the right terms and definitions when we communicate with others so we do send the intended message and it is received with the same meaning.