Kymanox® assisted the Quality Control (QC) department of a Contract Development and Manufacturing Organization (CDMO) review data, train key personnel, and support QC Out-of-Specification/Out-of-Trend (OOS/OOT) investigations, deviations, and Corrective and Preventative Action (CAPA) closures. Kymanox performed a deep dive into the deviation management system to identify focus areas for process improvements. Following this, Kymanox assisted this client with prioritizing and closing their deviation backlog.

Challenge

Identifying focus areas in the current deviation management system for process improvements and addressing the deviation backlog.

Solution

Kymanox executed a deep dive into the management system by creating a Pareto chart to highlight areas in need of process improvements and developing an organized table for tracking open and aged deviations. Kymanox addressed the deviation backlog with the following:

1. Creation of a deviation tracker with weekly updates to stakeholders

2. Development of an investigation tool to assist in root cause analysis

3. Provided subject matter expertise and oversight of deviation closures

4. Development and implementation of a new deviation management program

Results

Implementation of these programs and tools significantly improved the QC deviation backlog and provided alignment on deviation processing within the QC department. Kymanox helped to greatly reduce the risk for this QC department, which had previously been regarded as one of the most at-risk departments. This client was satisfied with the results of this project and requested extended support from Kymanox after the project was completed.