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Abstract:In 2004, the FDA launched a pilot program introducing a new risk-based audit model for pharmaceutical manufacturing sites. While typically the risk exposure of such sites involves the product, the process, and the facility itself, the new approach examines …

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There is no doubt that risk management is important and so often not given proper consideration by companies. Unfortunately, I was disappointed by this article, which raised some interesting considerations but failed to adequately explain each step in the audit methodology being presented. For example, how are the importance weights in Table 2 created? How are the contextualized weights (QFD%) used to further the analysis? How are the actual scores in Table 3 derived. All so complicated ... and, sadly, not well presented.
--Stephen Cummings, 09-25-2011

Great article. Risk management was presented, showing how important it is to the whole organization. Risk management is an organizational imperative indeed.
--BUDS FERNANDO, 09-08-2011