Interviews

An interview with Dr. Gordon Kapke, VP for Global Technical Affairs at Covance Laboratories. Dr. Kapke describes how Covance has applied the Six Sigma concepts without formally implementing an entire Six Sigma management program. You don't need to have a black or green belt to strive to zero defects.

Dr. Gordon Kapke, Vice-President for Global Technical Affairs, Covance Laboratories

Interview by Sten Westgard, MS

Dr. Kapke is Vice President of Global Technical Affairs for Covance Central Laboratory Services. He has 10 years of experience in centralized clinical laboratory services in support of clinical trials. He has been a direct participant in launching and operating all Covance's global sites. Prior to accepting a position at Covance, Dr. Kapke spent 10 years in a non-profit community hospital laboratory in technical and administrative positions. He holds a Ph.D. in Chemistry from the University of Iowa and is a diplomat of the American Board of Clinical Chemistry.

We are pleased to present this interview with Dr. Gordon Kapke. What Dr. Kapke has done at Covance is to implement process metrics without institutionalizing a methodology. Dr. Kapke shows us that by openly using process metric tools one can influence policy and set direction to improve quality.

Tell us about Covance first:

Covance Central Laboratory is a global laboratory network devoted exclusively to pharmaceutical clinical trials with laboratories in Indianapolis, Geneva, Cape Town, Sydney, and Singapore. Each laboratory operates with the same methods and information systems to produce consistent data that can be merged without additional statistical analysis and hence data generated under these conditions is referred to as combinable data. Covance's mission is to lead drug development through science, service, and shaping solutions. Covance Central Laboratory can provide labs services to all regions of the globe generating more than 2 million reported results per month. The relative sizes our global labs are: Indianapolis = 10, Geneva = 4, Cape Town = Sydney = Singapore = 0.2.

How did you first learn about process metrics?

I have been searching for ways to compare our global laboratory operations and also determine what is the quality of our operations. I am frequently challenged on different aspects of our global operations and could never clearly explain the quality of our processes. I actually was inspired by Westgard's book "Six Sigma Quality and Design and Control" to collect and post my internal data in ppm and sigmas. Although the majority of your book talks about lab measurement control, I was very interested in the process quality measurement discussion. In your book you introduce the concept of measuring process quality not only in ppm but also in sigmas. When providing information to a customer, being able to talk in sigmas provides an easily recognized benchmark for world-class quality which is 6 sigma or 3.4 ppm. I was also very interested in how our process quality related to the benchmark of 6 sigma and in comparing our lab operations globally on a normalized scale. Talking about quality in sigmas provides the across industry comparisons and across lab comparisons that need to be made to provide guidance for process monitoring and improvement.

What value do you see in Sigma quality measurements for Covance?

By measuring quality in ppm and sigmas I am able to look at quality trends over months with fluctuating volumes and understand what our defect rate has been and if it changes with changing stresses on the operations. The data is an indispensable management tool. I can also isolate processes and measure the specific process in a quantitative manner. I find the data presented in sigmas to be very easy to discuss with personnel of all backgrounds and easy to compare across and among laboratory operations. In addition, publishing the defect rates has prompted all managers to look more closely at process improvement opportunities within their operations. Everybody wants a high quality process and the data demonstrates the difficult challenge to achieve a high sigma performance.

Will Covance be instituting a formal Six SigmaTM program?

Covance North America Labs is implementing a formal Six SigmaTM program. However, the rest of Covance does not currently have a commitment to a Six SigmaTM program. After reading your book, I am using the data to monitor processes globally and look for opportunities for organizational improvement. I am also using the process metric data to educate customers to set realistic expectations for performance. All lab customers expect perfection. By isolating processes and looking at defect rates in a very quantitative manner one can clearly explain the quality of a process, quantitatively measure if the process quality is improving or declining, and understand if a process is meeting a quantitative expectation.

How was the data gathered?

The performance data is extracted monthly from our lab databases globally. We have standardized the cancellation codes worldwide, and therefore we can generate a monthly report of all lab cancellations and lab testing volumes to determine the organizational performance. Due to the processes that we have in place and the cancellation code standardization, we can actually look at processes that are more than just lab processes. Covance has system driven processes to determine specimen stability and container expiration as a result of our customized predefined project database and our customized collection kits. As a result of pre-labeling containers with accession numbers at the point of collection kit assembly, we know what is in the kit related to container lot numbers and expiration dates and also the testing to be performed on each returned specimen. The container information is linked to the accession and container number in the master database. At the time of specimen accessioning, our system will check for expired collection containers and also look at the time between collection and lab receipt and determine if the sample meets the preprogrammed stability requirements for each ordered analyte. If stability is exceeded, the system automatically cancels the testing and the specimen is not routed to the analytical workstation. The data is generated and published by one person globally and placed on a common drive for all company personnel to access. The data is also provided to customers upon request. The data was gathered because I was searching for a quantitative means of monitoring process quality. For areas of concern or in response to changing conditions, we will use the data to Define-Measure-Analyze-Improve-Control the processes. The publication of the data has also had a positive cultural impact as everyone is interested in knowing the organizations quantitative results and using the results with their work groups to foster process improvement.

Did the observations and metrics match with expectations?

I was unsure what to expect before I generated the metrics. I knew that out of stability samples were an issue but felt the issue was small as we track "wrong day late" kits. We knew that "wrong date late" cancellations were generated by less than 1% of our freight . "Wrong day late" means that the specimens were received 1or more days after we expected to receive the collected specimens. We determine "wrong day late' from the shipping location and the day of receipt. Sites are 1 or 2 day ships so if the expected time of shipment is exceeded and the system generated an out of stability cancellation, we review the courier's performance. The data demonstrates that courier and site determined ship dates result in the largest amount of lost data above any other single process and more lost data than all the other measured processes combined. Courier capabilities are not consistently well defined around the world, which is reflected in the varying results obtained at our different facilities, with some sites having twice the lost data due to transportation than other sites. The second largest loss of data is due to sites not monitoring the expiration date of kit containers. Covance places the shortest expiration date on the outside of the collection kit so that sites can easily determine if all containers are within their expiration period at the time of use and yet this is the second most frequent reason for lost data. The data shows that focusing on pre-analytical issues has the greatest opportunity to improve data yield. I carefully monitor variables that the laboratory can directly control and use the metrics to take actions that can improve the process performance. I monitor Tests Lost Due to Broken in Transit and Tests Lost Due to Microclot Specimen as a means to assess the quality of our packaging as well as the courier's handling of our freight. Tests Lost Due to Hemolysis is a good indicator of site phlebotomy performance as in Indianapolis and Geneva these results come directly from the chemistry analyzer's hemolysis index. Globally, the phlebotomy performance of sites seems quite consistent.

What is the financial cost of current performance?

I have not quantified the cost of current performance. We do have a major costing project in progress and I expect to watch costs and the lab metrics in the future and work to demonstrate that improved quality does indeed reduce costs.

What happens next?

I will continue to look for additional quantitative performance data that can be appropriately generated. I will use this data to influence process change and to monitor the effect of process change on the overall quality performance of the company. I am also looking for data from other sources so I can compare organization performance and identify where resources can be most effectively applied to yield process improvement.

Thanks again for letting us get a glimpse of real-world process metric performance.