Description

An existing client approached Kymanox with a backlog of thousands of complaint investigations that had not been performed. After a review of the internal process for complaint investigation, handling and close out, the client asked Kymanox to create a systematic approach to performing an investigation into these complaints for their portfolio of combination products and closing these investigations out to satisfy compliance needs.

Challenge

Thousands of complaint investigations need to be performed for a Fortune 500 client to satisfy compliance requirements.

Solution

Kymanox provided a more expedient, efficient and effective approach to resolve this backlog of complaint investigations.

Results

Kymanox has already supported this client with remediation of Design History Files (DHFs) for these combination products, becoming de facto subject matter experts in these products. Having this intimate knowledge of these products, as well as an understanding of the Client’s internal systems and key stakeholders, Kymanox provided a more expedient, efficient and effective approach to resolve this backlog of complaint investigations.

Kymanox delivered enough resources and key technical personnel to accommodate the required needs to perform these investigations, review the root cause analysis, and provide direction for next steps (closeout, CAPAs, potential further needs) for our client. Kymanox is also providing program management support to the client by providing key leadership guidance on status, direction, escalation and reporting for this program.

This complaint investigation support program is ongoing. Thus far the Kymanox team has been successful in setting up the appropriate system to address and resolve the complaint investigations, is providing key support needed to complete the required investigations, and has ramped up efforts to accommodate the required output to maintain weekly metric requests.