Complaint Handling for Japanese Medical Device Manufacturer

Project Statistics

  • RQMIS Project Team – one manager and 5 team members
  • 12,000 complaints closed in 7 months
  • 109 Master Investigation Templates
  • 15 device families
  • 330 primary failure modes identified

The North American division of a Japanese medical device manufacturer approached RQMIS with the need for support in addressing observations identified in an FDA Warning Letter regarding Complaint Handling, including the timely investigation and closing of complaints. Specifically, they had a backlog of 10,000+ complaints that had to be processed, investigated, and closed.

After a 45-day competitive process between RQMIS and another consultancy, RQMIS was selected as a provider of choice. Upon winning the contract, RQMIS assigned to the complaint handling project an expanded team consisting of QA specialists, Regulatory Specialists, Technical Writers, and Operations Analysts, with strong backgrounds in complaint handling and Post Market Surveillance regulations. RQMIS developed advanced tools which, when applied to report data, generate a list of related complaints by conducting a keyword search of various data sets. This has made complaint categorization, handling and trending more repeatable and reliable. These tools have also been useful in speedily categorizing complaints for processing.

To streamline the writing of Risk Assessment, severity, probability, and root cause investigation language, we have written 109 Master Investigation templates over 7 months that we use to resolve complaints across 15 device families and 330 different failure categories. These templates are used to answer complaints against similar devices with similar complaint failures recorded. This greatly reduces the time needed to research and record each complaint.

The client has adopted the tools we have created and implemented them into their complaint-handling workflow.

Since being awarded the contract RQMIS has closed over 12,000 complaints in 7 months.

After incorporating our new process, RQMIS completed the backlog of complaints assigned. Using our enhanced process, the client can more efficiently process and close complaints, with RQMIS now in a supportive role as needed, which allows the client to reduce their internal costs.

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