The purpose of this paper is to discuss a practical approach taken by utilizing the non‐conformance/event management and failure investigation (FI) system to formally troubleshoot an actual process failure observed in the sequencing facility.
In this study the authors describe how the cause for the poor quality sequence data, as indicated from the quality score, involving high molecular weight follicular lymphoma DNA samples for a study of tumor‐associated genome rearrangements was successfully identified and confirmed through the application of a well structured FI process.
Through this FI process the underlying causes were effectively identified, immediate corrective actions were executed and a preventative action to avoid or minimize reoccurrences was also implemented and monitored for effectiveness.
This paper establishes that by applying a systematic, documented FI process the underlying causes of a process failure in an organization can be effectively identified and appropriate corrective and preventative actions can be successfully adopted.
