Site Seeing

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 regulatory compliance history, quality metrics, and organizational culture and uses them to compose a Site Risk Profile, from which is calculated a Site Risk Score. The facility quality audit should be preceded by an audit preparation process that determines the focus of the audit and the elements to be audited. Once the audit has been conducted, analysis should consist of setting site-contextual information, assessing the measures of compliance history, quality, and organizational culture, and using these measures to create a Site Risk …

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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

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