First Pass Yield Metric Implementation for Validation Documents

Abstract

A regulatory compliance contractor in the life sciences industry desires to be distinguished from its competitors in terms of the quality of their services. To make it possible, the company intends to improve the validation test case development process in order to implement a metric that shows how much time they are saving their customers by delivering defect-free test cases to the approval process. This metric is known as the First Time Yield and measures the proportion of documents that are reworked during the approval process. To achieve this goal, the DMAIC methodology was used to gain a better insight of the process and the areas of opportunity. After following this structure, the baseline FPY value was improved from 66% to 80.5% with only the first stage of solutions proposed. This improvement reduced 6-15 hours of re-approving defective test cases. With this reduction, the client can allocate their resources into more valuable activities while complying with the project deadlines. Key Terms - Defect, FPY, Rejections, Validation.