Complaint Management Capabilities

At Kymanox®, we use a strategic investigation approach to eliminate complaint backlogs and identify appropriate corrective actions for medical devices, drug products, and combination products. The Kymanox quality team works with our clients to proactively identify roadblocks and bottlenecks that slow down progress. We collaborate with your Device, Pharma, Quality, and Manufacturing teams to ensure investigations are thorough and accurate by identifying patterns and trends to streamline the investigation process. Our experts can provide process guidance documents to assist investigators, including full investigation procedures and decision trees for failure mode determination or root cause analysis. Kymanox can also assist with investigation reviews and create or manage spreadsheets.

Streamlining the Complaint Investigation Process

The Kymanox quality team can help to streamline the investigation process by authoring process guidance documents, internal work instructions, and procedures. We have developed several optimization strategies to keep projects on track and improve output and consistency, such as, creation and management of spreadsheet-based databases for live tracking of status. Our quality subject matter experts know how to identify and eliminate any roadblocks or bottlenecks impeding the complaint investigation process. We cross-reference any failures we encounter with common failures seen in post-market surveillance for similar products.
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Complaint Investigations

Our quality team has experience authoring, reviewing, and approving complaints and investigations for all types of products, including medical devices, combination products, and diagnostics. We take a collaborative, holistic approach by working our clients’ device, pharma, quality, and manufacturing site teams to ensure investigations are thorough and accurate and adhere to agency guidelines and regulations.
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Root Cause Analysis

Kymanox uses root cause analysis techniques including fish bone and fault tree diagrams.
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CAPA Implementation

At Kymanox®, we use a process-focused approach to author deviations, perform a quality review of open deviations from progress to closure, and review closed deviations and CAPAs to determine areas for improvement. Kymanox has helped clients streamline their CAPA closure process by performing gap assessments of current procedures against regulations and reviewing closed deviations and CAPAs to establish metrics and Key Performance Indicators (KPIs). Additionally, we provide clients with a complete overhaul of their deviation and CAPA program and train employees on new procedures.
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