Case Studies II

Summary

A medium sized blood analyte testing firm had a notified body audit upcoming, and their high CAPA count from their last audit, 72 CAPAs, had not come down. The audit was in 2 weeks; what could possibly be done? An InSync Solutions LLC Critical Path Management™ services project manager was diverted to the rapid CAPA reduction project.  The rapid CAPA reduction project had two QA consultants, all the QA function resources that were not involved in testing or releasing product, as well as the highest priority in the company with the exception of production. The timeline was too short for planning. So, the project required a CPM project manager with an excellent project critical path intuition.

One of the QA consultants noticed that many of the CAPAs had a similar subject, so these were grouped together into one all-encompassing CAPA, reducing 18 CAPAs into 1. Next we had to analyze the remaining 54 CAPAs to determine which ones could be closed within two weeks. We selected 19 CAPAs that were in various stages of completion. Many were stuck getting final approval cross-functionally. This is where the high priority of the rapid CAPA reduction project really helped us. The cross-functional CAPA approval issues became much less contentious once the pressure of the notified body audit was felt by the organization, and the seven CAPAs in the approval cycle reached cross-functional agreement.

Which left 12 CAPAs that we needed to finish within twelve days, for we were working weekends; it was a tall order. This is where the Critical Path Management™ services were essential. There weren’t enough resources for CAPAs to have individual owners, so the CPM project manager had to direct the effort task by task across all 12 CAPAs, ensuring that critical path didn’t slip in any of the CAPAs. The CPM project manager also had to prime the cross-functional approvers for each CAPA, so that they would know when to expect them. The team was successful in executing the rapid CAPA reduction project tasks, the cross-functional CAPA approval cycle went smoothly, and as a result, the company’s CAPA count went from 72 to 36 in two weeks!

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