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Theory and Application of J Charts for Holistic Risk Based Statistical Adverse Event Trending

The author attempts to postulate a new volumetric complaints and adverse events trending method for holistic risk based statistical trending using a new control chart which is based on the theory of a U chart, as it pertains to medical device failure related adverse events. Mathematical rationale is provided for various control chart parameters like subgroup size and subgroup frequency and correlations to existing literature have been made to justify conclusions. Also, the article features discussion on false alarms and how to use Minitab to minimize them while monitoring incoming complaint variability using a U chart and consequently, the J chart.