Situation
- Client developed a new supplier risk program and in the course of execution identified a need to close 100% of CAPAs in 2009. Unfortunately, the client did not have the resources or bandwidth to complete this project in the timeframe set.
Challenge
- Client had never outsourced CAPA management to any third party company in the past. Naturally, the client was concerned about the process by which the CAPAs would be closed, the volume and meeting the timelines defined by client to close a CAPA.
- Multiple stakeholders (client, suppliers, & SQA) were involved, therefore coordinating and tracking communication, information and documentation was a major challenge. There were multiple contacts at a variety of client sites around the world working with SQA to manage the corrective actions and numerous suppliers found globally which made streamlining the CAPA process an enormous task.
Solution
- SQA provided Client with a clear, simple, and effective process to manage CAPAs with minimal error in the fastest time possible.
- SQA’s dedicated CAPA Team used STEPQ as the vehicle for communication and information flow for all client and supplier stakeholders. STEPQ’s CAPA features such as the Ford 8D model, communication logs, history tabs, notes section, automatic notifications, and interactive approve and reject options allowed the client to stay connected with the activities that SQA was managing.
- SQA’s dedicated CAPA Team reached out to the suppliers at least once a week, thoroughly reviewed the suppliers’ root cause analysis and problem solving plans, and uploaded observations and actions taken by the supplier while simultaneously keeping the client involved.
Results
- SQA was able to close 289 CAPAs in 2009 for the client within an average of 45 days.
- SQA and Client signed an agreement to continue the partnership for an additional 3 years.
- SQA enhanced the CAPA program for the client to meet the client’s internal CAPA process.
To learn more about SQA's Managed CAPA service
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