Pharmaceutical QC labs gain superior performance and productivity using lean principles

May 22, 2018

Lean principles have long been used across multiple industries as a way to improve and streamline manufacturing operations. This proven strategy is transformative, and pharmaceutical companies employing it frequently find that by incorporating it into their production processes, they are able to achieve greater levels of predictability, lower error rates and a “right-first-time” environment.

Although lean strategies are most frequently associated with production, the principles apply in other areas with equal success. Pharmaceutical QC labs may be missing out on an opportunity to deliver improved results, simply because the lab is seen as outside of the production area – but it need not be so. QC labs can achieve extraordinary results.

In particular, lab throughput time, or the time between when a test sample arrives in the lab, testing is completed, and data released, is often a source of frustration and needless complexity. These common challenges can be overcome by applying lean principles to the QC lab.

Overcoming perception

The biggest challenge in bringing lean principles to the QC lab is not in its difficulty, but in its perception. Lean is best-understood in manufacturing. While the principle applies readily to lab operations, it is less understood in that area. Also, because the lab is not part of the production process, the same expectations for operational excellence may not apply.

There is also a significant difference between streamlining, and elimination of waste in the lab. Streamlining a sample scheduling process, without addressing wasteful processes, will still result in the same problems and challenges.

Labs will often have multiple scheduling tools, ranging from formal implementations to spreadsheets and other informal mechanisms. These scheduling tools are usually not integrated, which results in duplication of effort and limited visibility, and sample scheduling accounts for more than 13 percent of the lab's operational time. This wasteful approach represents an area that can be significantly improved by applying lean principles.

When the lab does not acknowledge the interdependencies that exist in those scheduling tools, the entire manufacturing cycle will suffer. This lack of understanding results in peaks and valleys in scheduling, which in turn results in less efficient use of the testing facility.

A better approach

Those organizations which recognize the lab as part of the overall production environment have an advantage. In one case study, a pharmaceutical company suffered from unnecessary complexity in scheduling and coordinating tests. Applying lean principles allowed them to reduce their throughput time by 30 percent within three months.

Eliminating the manual process achieves the desired results, replacing it with a system of visual cues and a “pull” sample management system firmly rooted in lean principles. Elimination of manual scheduling contributes to the goal of creation of lean building blocks and improving overall performance.

Lean works as well in the QC lab as it does in production, because it is a management principle that can apply almost anywhere. Coordinating all functional groups, and establishing a mechanisms to balance the workload against capacity, reduces the bottlenecks that always occur in manual scheduling. Capacity as a result, is always available to meet the highest level of demand – while still keeping staffing requirements at a minimum. Scheduling improvements and reduction of waste smooths out the peaks and valleys, reduces variability in cycle time, and eliminates sample demand volatility.

Six steps are involved in achieving the type of transformation needed in the QC lab:

  1. identify how the lab creates value
  2. map out the entire value stream, including inputs and outputs
  3. target waste reduction that affects throughput variability and speed
  4. level the lab’s load and sample mix
  5. create a pull system to move samples through the lab more quickly
  6. measure performance.

Some of the key elements in improving productivity and predictability through a lean process include first, gaining a stronger understanding of internal and external factors which affect productivity and the lab's capacity. The process requires the creation of a team, which includes representatives from every area of the value chain, including manufacturing, QA and QC, packaging, planning, and scheduling, and implementing visual cues to manage sample flow and identify opportunities for improvement. By doing so, it is possible to smooth out the demand peaks, reduce waste, and increase productivity.

A New Perspective

In the case study, the team analyzed the previous year's workload and saw a major variation in sample type and volume. The team understood that increased capacity would come through improvements in productivity, speed and predictability.

Through application of lean principles, the team was able to achieve a 22 percent reduction in conversion cost, reduced testing turnaround time by more than 50 percent, and increased analyst productivity by more than 25 percent. RFT went from 95 percent to greater than 99 percent, without having to incur any additional increases in equipment and personnel costs.

The lean initiative allowed the group to gain a deeper understanding of how the different functional groups interacted, while creating a new perspective on older entrenched processes.


About the Authors

Scott Myers, senior managing consultant at Tunnell Consulting, has more than 25 years of experience in technical, managerial, and business leadership in the global pharmaceutical industry. He is adept at identifying and controlling risks associated with development and commercialization of pharmaceuticals. Myers is known for his expertise in the interpretation and execution of domestic and international cGMP requirements. Prior to joining Tunnell, he was executive director, compliance and quality oversight at Boehringer Ingelheim (Bedford). Myers was responsible for setting the company’s strategy for the interpretation, auditing, and execution of those requirements. He led the compliance and environmental, health and safety (EHS) teams. You can reach him at
Greg Anthos, senior managing consultant, brings to Tunnell over 30 years of experience in the life sciences industry. He is adept at strategy development and execution, change management, operations management, and program/project management. He is a seasoned operations leader with significant experience in engineering, organizational transformation, and supply chain. Prior to joining Tunnell, he spent 30 years at Merck & Co., most recently as executive director, business consulting, where he was a program leader in charge of transforming a 2,000-person global regulatory affairs function. He is a Lean Six Sigma Master Black Belt as well as Change Agent II and Process Improvement Master. You can reach him at

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