A well known medical devices company was under Consent Decree and in desperate need of special expertise to help them get out of it sooner so they can resume their business. So, they contacted Synergy and we dispatched 22 of our consultants to expedite their remediation effort. Several of their business processes had compliance issues and we were asked to start with the Corrective Action/Preventive Action (CAPA) process. The initial review showed the need to overhaul the entire CAPA process, build a new one, and provide extensive training to the entire organization as part of organization cultural change, which we were successful in doing. Then, we started clearing of a very large backlog of open CAPA records, some of them were as old as 3 years back. As part of this effort, we had to validate the EtQ software platform and mentor the CAPA investigators on how to properly investigate for identifying and confirming root causes, using the quality risk management as the basis for their investigation. Furthermore, optimizing the CAPA process and clearing the backlog exposed other processes that needed our immediate attention as well, such as product complaint handling and manufacturing process nonconformance investigations. To ensure sustainable compliance of the company’s quality system, we had to improve the internal audit program of the organization and mentor the company’s internal auditors while performing their internal audits. Then, we moved to prepare the company for the next FDA recertification inspection. Our effort helped the company get out of their consent decree after only 19 months from our involvement date.
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