Five Questions with Tim Mohn, Industry Solution Director, Sparta Systems.1.Why are customer complaints important to medical device companies?Device manufacturers are required to record, track and trend customer complaints according to the Quality System Regulation (QSR) defined in 21 CFR Part 820. In addition, FDA Part 803 regulations require firms that have received complaints of device malfunctions, serious injuries or deaths associated with medical devices to notify the FDA of the incident.

April 10, 2012

2 Min Read
Your Call is Important to Us: Managing and Resolving Customer Complaints in an Enterprise Quality Management System

Five Questions with Tim Mohn, Associate Director, Enterprise Quality Management Systems at Johnson & Johnson

1.Why are customer complaints important to medical device companies?

Device manufacturers are required to record, track and trend customer complaints according to the Quality System Regulation (QSR) defined in 21 CFR Part 820. In addition, FDA Part 803 regulations require firms that have received complaints of device malfunctions, serious injuries or deaths associated with medical devices to notify the FDA of the incident.

2.How do device companies typically manage this process?

This varies by company, but most struggle to maintain global visibility to the entire complaint process. Many companies have multiple layers of systems, from call intake systems supporting regional call centers to service and repair systems to inventory systems to CAPA systems. These are all designed to meet a specific business need, but none are designed to manage the holistic complaint handling process.

3.Why is this a problem?

This disjointed approach makes it difficult to truly understand what’s happening within the complaint system and more importantly, can result in missing indicators of alleged patient risk. Furthermore, the disconnected nature of these solutions is inefficient, and can add regulatory scrutiny due to compliance challenges like missed reportable events or failing to adequately investigate issues.

4. What should companies use instead?

Companies should seek to implement one global system that aggregates all sources of complaint data and centralizes the investigation and regulatory reporting aspects of complaint handling. Many companies deploy an Enterprise Quality Management System (EQMS) for this purpose, seamlessly interfacing to the multiple up-front call capture and service systems and ensuring timely regulatory reporting and CAPA activities.

5.What does EQMS offer?

Among a multitude of other benefits, EQMS lets companies automate the process of assigning complaints and related investigations based on manufacturing location, product type or any other criteria they establish. Additionally, it helps organizations error-proof their processes by utilizing decision trees, specific to their products, to help drive investigations and determine regulatory requirements around the world. Finally, EQMS facilitates improved compliance by providing companies with templates and electronic reporting capabilities to ensure the consistency of complaint data when it comes time to submit it to the proper authorities.

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Tim Mohn Associate Director, Enterprise Quality Management Systems at Johnson & Johnson. He was previously the industry solution director at Sparta Systems and the former manager of worldwide quality systems for Johnson & Johnson Ortho-Clinical Diagnostics. Mohn is widely recognized as a key thought leader on quality and compliance issues in the medical device market.

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