Vendor Column: Using Lean Six Sigma principles to improve Laboratory Execution at the Bench

Continuing the discussion on Lean Six Sigma and Laboratory Informatics from "Improving Laboratory Operations Using Laboratory Informatics for Lean Six--Sigma Initiatives", let’s examine case studies focused on bench-level workflows that were migrated to an electronic laboratory notebook (ELN).

Contemporary ELN’s are much more than a diary for recording observations. They serve as a focal point for interacting with other electronic systems, allowing for the consolidation of information into one electronically traceable location. For example, an analytical ELN can interact with a Laboratory Information Management System (LIMS) to collect sample information (lot number, testing specifications, etc.) for testing, connect to an analytical balance to weigh samples, and then compile all information into a worklist to be sent to a Chromatography Data System (CDS) for acquisition. After testing is performed, the results can be compiled into simple dash board summaries to aid the reviewer in approving the tests. The following two case studies demonstrate the ability of an ELN to reduce waste and variability in laboratory workflows.

In the first case study, a top ten pharmaceutical company sought to improve the efficiency of laboratory testing operations by removing the waste and variability associated with utilizing and managing the ubiquitous paper logbooks. In addition, the company was interested in storing information electronically to improve data review, minimize transcription errors, and support the data traceability required for regulatory compliance. Logbook entries used by the company included preparation of samples and standards, preparation of solvents and mobile phases, and instrument fit-for-use checks. As with most laboratory informatics projects, the use of the ELN for managing the logbooks was a part of a larger laboratory informatics environment, including LIMS, CDS, and other systems to automate and manage data flow. Deployment of the ELN with standardized electronic execution methods (similar to a paper worksheet) allowed the organization to:

• Replace over 1,000 paper log books
• Eliminate illegible handwriting
• Facilitate easy log retrieval for audits and investigations
• Eliminate transcription errors (e.g., through the use of bar code scanners for direct information transfer).

Through this effort, the company was able to realize:

• 75% time savings by consolidating information formerly captured in paper notebooks to increase the efficiency of documenting standard preparations
• 80% time savings by verifying that a balance was fit for use before conducting a weighing operation
• 33% time savings by consolidating information and creating an instrument work list (using the ELN as a focal point for information capture and transfer) for the CDS.

The total yearly savings for this project was approximately $500k per year.

In the second case study, another top ten pharmaceutical company sought to improve drug development by implementing an ELN as a focal point for the laboratory bench. First, the company mapped their existing laboratory informatics infrastructure and proposed systems (e.g., ISA 95) "Reducing System Complexity by Standardizing Laboratory Informatics Solutions". Then they conducted an analysis of laboratory workflows to better understand the individual steps of these processes. Once the individual steps for common tasks were clearly defined, such as weighing samples and creating sample sets for the CDS, they measured mouse clicks and surveyed users regarding the level of manual steps required for individual operations. For example, how time-consuming do you rate the manual transcription of information from LIMS to the CDS; from CDS to LIMS; from CDS to paper notebook, etc.? Once establishing baseline workflow and time spent at each step, a dollar value was assigned. The company then set specific goals for each step, such as minimizing variability in data transfer, by minimizing manual transcriptions. The company realized that if they were to automate information exchange between IT systems, those systems would have to share a common vocabulary. To this end, the meta-data used within each system was standardized.

At this point, they were ready to define the user requirements and select the ELN. Once the ELN was selected and deployed, the company went back to the original workflow measurements to determine if they had met their objectives. Using the ELN as a focal point into LIMS, CDS, balances, pH meters, etc., they were able to achieve their primary objective of minimizing waste and variability with information exchange between these systems. A cost savings of $3 million per year was derived from implementation of the ELN as a simple information hub and automated exchange vehicle.

An unexpected benefit of the Lean Six Sigma workflow analysis was that the ELN adoption improved the quality of the notebook entries as scientists were more willing to enter information into the experimental record given the overall reduction in manual input and intervention.

In summary, Lean Six Sigma helped drive both projects by justifying the need to migrate from paper to an ELN. Both companies derived significant cost savings and improvement in data quality by reducing waste and variability in information consolidation and exchange.

Article by Chris Stumpf, Waters Corporation

• Read more about Chris Stumpf and our other columnists >>>

The views represented in this article are solely those of the author and do not necessarily represent those of John Wiley and Sons, Ltd.