Tracking and controlling everything that affects quality is the key to a quality management system

Every laboratory has a need to track and control the variables that drive the quality of the results. However, each laboratory is unique and what one organization deems to be a critical process to track and control will likely differ from other organizations. Furthermore, there is more than just the end product or result that needs to be tracked and controlled. All of the intermediate products and resources play a significant role in producing the final product and each of these needs to be included in the LIMS. At a high level, this article will present ideas and opinions on the following topics in relation to implementing a LIMS process tracking and control system in a laboratory: The difference between tracking and controlling processes; What to track and control in the lab; The "product" of the laboratory; Preventing mistakes in a laboratory; Comprehensive software platform options; The value of seeing a system as opposed to imagining it; The use of barcodes in the laboratory; and an assessment on using the Risk Based Approach in deciding what to include in the tracking system.