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Seeking the Golden Mean: Optimizing Your QRM Program

机译:寻求金色意味着:优化您的QRM程序

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Recall the struggle that Goldilocks experienced when she was trying out chairs to rest her feet: "This chair is too big!" she exclaimed. So she sat in the second chair. "This chair is too big, too!"she whined. So she tried the last and smallest chair. "Ahhh, this chair is just right," she sighed. If you were tasked with assessing your Quality Risk Management (QRM) program, would you find yourself in the "just right" category? Characterizing the maturity of a QRM program includes the assessment of multiple parameters including the people, risk culture, QRM initiation, risk assessment, risk control, risk review, risk communication, infrastructure, and governance.2 Two foundational elements are examined in this article: process and accountability. The process perspective evaluates the relative effectiveness of the QRM program strategy, documentation and the ability of the organization to derive value from the program. The accountability perspective considers program ownership and organizational engagement. Process and accountability perspectives, in combination with understanding the cultural climate, can help us shape the Golden Mean or "just right" program size.
机译:回想一下,当她试图休息脚休息时,金发姑娘经历的斗争:“这把椅子太大了!”她惊呼。所以她坐在第二椅上。 “这把椅子也太大了!”她抱怨。所以她尝试了最后一个最小的椅子。 “啊,这把椅子恰到好处,”她叹了口气。如果您有任务评估您的质量风险管理(QRM)计划,您会在“公正的正确”类别中找到自己?表征QRM计划的成熟度包括评估多个参数,包括人民,风险文化,QRM发起,风险评估,风险控制,风险审查,风险沟通,风险沟通,基础设施和治理.2在本文中审查了两个基础元素:过程和问责制。过程透视评估QRM程序策略,文档和组织能力从程序中获得价值的相对有效性。问责制透视考虑计划所有权和组织参与。流程和问责制的观点与了解文化气候,可以帮助我们塑造金色均值或“公正的”计划规模。

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