This article reflects that Quality Risk Management (QRM) is operating in a different technological environment since the ICH Q9: Quality Risk Management [1] guidance was first published in 2005. This paper explores the array of risk management systems that influence operations in a typical modern high-tech manufacturing facility. These ‘other’ risk management systems, either directly or indirectly, inform both the risk assessments and the control strategies developed by QRM. Convergence is another word for coming together. In order to assure that QRM can fully align and converge within operations, it must also ensure that it can align with these allied risk management systems.



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Creative Commons Attribution-Noncommercial 4.0 License
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