Change Control Routed with Missing Information Delaying Approval and Implementation Date

Abstract

The approval of manufacturing change control for MedDevice Inc., is currently acting lower than target(15 business days). Based on a 12-months data review, the lead time of approval of a change is approximately 36 days. This means that 25.8% of changes were routed for evaluation without the necessary information. The DMAIC methodology was used to determine what is causing the delay. The following possible causes were identified as part of the evaluation: (1) missing information i.e., Manufacturing Plan, Validation documents, and Product affected is not included. (2) Volume of changes being routed. (3) Time for identification and number of required approvers by type of change. During control phase, lead time for four months (Quarter 2) was collected, and results demonstrate a reduction of less or equal to 33 business days. The project goal was to reduce approval lead time process from 36 to 33 days by end of Quarter 2.KeyTerms⎯Change Control, Continuous Improvement, DMAIC, Lead Time.