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Strategies for Addressing the Problems of Subjectivity and Uncertainty in Quality Risk Management Exercises Part I—The Role of Human Heuristics | IVT

Notwithstanding this, in the good manufacturing practice (GMP) environment, many existing risk management tools do not formally deal with the problems of subjectivity and uncertainty that can arise during quality risk management exercises. In fact, most of the currently available tools do not provide any formal strategies for addressing such problems.   This paper is the first of two papers that further develop some of the points made in an article published in the Journal of Validation Technology in February 2007 (10). The 2007 paper, titled “Simple Strategies for Improving Qualitative...

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