Quality in the service industry is difficult to maintain due to complex processes. It is estimated that 30-50% of the costs in a service organization are related to process inefficiencies as well as the challenges of meeting individual client requests.¹

Several techniques have been developed to improve processes in the service industry, such as Business Process Modeling (BPM), Total Quality Management (TQM), Continuous Quality Improvement (CQI) and Lean Six Sigma (LSS).²

Lean Six Sigma principles
LSS is a business management strategy originally developed by Japanese manufacturing industrialists to improve product quality and decrease production inefficiencies and costs.² There are two distinct components to the LSS strategy—Lean and Six Sigma.
Lean represents a systematic process management approach by which inefficiencies are eliminated. It begins with assessing work flow via “value stream mapping”² to identify areas that need improvement. Processes are improved by eliminating non-value added activities that absorb time and resources, such as unnecessary process steps or production downtime due to delays in an upstream process.

Six Sigma aims to improve quality by managing “quality at the source” and reduce process variation and defects by using a robust and systematic five-step approach known as DMAIC (see figure 1) to help organizations strive for excellence and a competitive edge.

Figure 1: Five-step methodology (DMAIC) of Six Sigma¹

LSS combines the best of Lean and Six Sigma models to provide a customer-service driven, systematic and measureable process improvement model that can significantly impact clinical research and drug development by decreasing cycle times and expenses while simultaneously improving deliverables and customer satisfaction.²

LSS concepts initially were applied to health care and pharmaceutical industries in the 1980s.²  The U.S. Food and Drug Administration (FDA) and other regulatory agencies adopted the methodology to shift to a process and quality improvement-centered approach in order to increase safety and quality control defined by current good manufacturing practices (cGMP). In 2009, the National Institutes of Health (NIH) developed a road map for medical research in an effort to improve clinical research processes by funding research institutions through the Clinical and Translational Science Awards (CTSA) program.² LSS is now used widely in the clinical trial industry by pharma companies, contract research organizations (CRO), laboratory vendors, Phase I units and Institutional Review Boards (IRB).^2,3

However, LSS and other process improvement methodologies are highly disciplined processes that require trained process improvement analysts to guide project teams through the rigid methodology. The programs are resource and time intensive, making them difficult to implement and execute.

This article addresses the use of LSS principles in the CRO industry by focusing on typical client services, such as customer progress reporting, contract negotiations and team communications, to identify opportunities for enhancement beyond process improvement initiatives. The authors suggest that LSS techniques are relevant for the daily work outside of the rigid process improvement methodology because they allow teams to identify innovative solutions that create value for the customer by challenging the status quo and viewing their work from the customer’s perspective. In addition, this article points out that LSS can benefit the individual through increased ownership and job satisfaction.

Five lightweight techniques using LSS principles in your daily work
If you doubt LSS principles could support your daily work, you should ask the following questions: Do I ever wait unnecessarily because an upstream activity was not delivered on time? How often do I have to chase down information to complete a task? Do I ever redo work because something failed the first time? Do the processes I use include unnecessary steps, lead to duplicate efforts or frustrate because of their unpredictability? Is information I need ever lost? Does communication ever fail? Am I confronted with an unhappy client due to a low-quality deliverable or significant variation in quality over time? If you answered yes to any of these questions, then you need to ask why, how can it be changed, what can be improved and how do you initiate these changes, as depicted in figure 2?

Figure 2: Flow diagram of executing change²

The following are typical issues a project manager in clinical research might face. By using a process improvement mentality with LSS principles, resolutions could be identified quickly.

Issue #1: Services that are not adding value to the customer (e.g., study progress report covering multiple non-relevant key performance indicators)

Tip: When working on a project progress report, you should consider which components are relevant for the customer. Ask for regular client feedback and include a checklist regarding the usefulness of key performance indicators with each progress report. Eliminate everything that is no longer required and try to automate the remaining data input in order to reduce the time for creating the progress report and to simultaneously improve quality for the client.

Issue #2: Significant variation in project process (e.g., development of a contract modification took much longer than expected)

Tip: When trying to solve a problem you want to identify underlying causes, which will help you prevent fires rather than just extinguishing them. The most common root-cause analysis (RCA) methodology is “Asking the Five Whys.” Follow these steps to identify the root cause: Bring relevant parties together, avoid “blaming the bad apple” and concentrate on the process breakdown. Discuss the potential root cause of the issue by repeatedly asking “why,” develop a solution, share lessons learned with stakeholders and establish some effectiveness checks of implemented actions. This will lead to improved learnings from previous errors, prevent recurrence and reduce variability of results.4 Here is an example:

1. Why did negotiation of the contract modification take significantly longer? Because there were hundreds of emails to review and act upon.
2. Why were there hundreds of emails? Because there were several revisions of this contract modification.
3. Why were there several revisions of the contract modification? Because the project team failed to discuss relevant changes with the client upfront.
4. Why didn’t the project team discuss the changes upfront? Because there wasn’t any guidelines available to cover prepa ration of a contract modification.
5. Why aren’t any guidelines available? Because nobody had escalated this before.

Without repeatedly asking why, one would simply have blamed the project team, only treated consequences rather than the root-cause, and the failure most likely would have reoccurred.

Issue #3: Process step takes too long (e.g., review and approval of documents)

Tip: Classically, people work to deadlines, which might unnecessarily increase the duration of process steps. However, buffers can be reduced when the mindset is shifted from working to deadlines to a first-in, first-out approach. For example, a manager has two weeks to approve a report, but the review only takes him one hour. In order to reduce the buffer, the team skipped the process step of the two-week waiting period and arranged for a one-hour meeting with the manager instead to review and approve the report.5

Figure 3: Pareto Principle¹



Issue #4: Facing delays in completing complex processes (e.g., negotiations of clinical trial agreements)

Tip: Employees need to have the Pareto Principle in mind, which explains that 80% of any delay is caused by fewer than 20 percent of activities. (see figure 3.) This means teams can focus on finding and improving the speed of 20% of the process steps to effect an 80% reduction in cycle time and achieve greater than 99% on-time delivery.¹ This is of critical importance in complex cross-functional processes like the negotiation of clinical trial agreeements.⁶ Check cycle times of single contract negotiation process steps and focus on the ones that are either easiest to influence (“low-hanging fruit”) or causing the most delay. However, you also need to be aware of the relationship of the contract process to other processes, which may lead to variations (e.g., training issues, team not well versed in financial management). In the end, incremental improvements will bring the mean average to an acceptable level.

Figure 4: RACI definitions⁸

Issue #5: Process not well defined (e.g., handling of protocol amendments at the CRO and at the investigational site)

Tip: If processes are insufficiently standardized, this leads to diverse interpretation of tasks and to differences in execution. You can accomplish increased continuity in handling a protocol amendment by clear delineation of responsibilities between operational functions (e.g., regulatory, project management and clinical). This is best achieved by developing a “RACI” document; i.e., a document that lists roles and responsibilities for each process step, as shown in figure 4. In addition, it is helpful to organize a formal upfront meeting to assess the impact of the protocol amendment and to amend site level implementation globally.
These continuous improvements will enable movement from reactive behavior to an innovative approach toward customer needs and operational excellence, as shown in figure 5.

Due to the major impact of the previously described LSS techniques, organizations have started to invest in providing basic LSS training to key service areas because process expertise is critical in today’s competitive marketplace. This strategy results in a beneficial culture shift toward continuous improvement and embracing change across the organization.

In essence, if companies adopt an LSS mindset, employees will quickly become more efficient and ultimately achieve operational excellence, which can help to accelerate clinical trials and meet or exceed customer satisfaction. Research shows these principles also can be successfully implemented in other areas of clinical research, such as in laboratories, quality assurance, pharmacovigilance and data management.^2,3

Creating value for the individual
While LSS has positive effects for the entire organization, it also has the potential to bring value to every individual by maximizing personal engagement. For instance, an LSS-focused organizational culture empowers people to speak up and gives employees a voice to flag all non-value added tasks. Trained LSS employees increase their influence on others in process improvement initiatives across the organization. LSS is a learning opportunity that helps develop and broaden individual skills that are recognized as world class and respected across all industries. And finally, LSS knowledge increases job satisfaction by enabling increased ownership and the ability to take action to improve processes. 

References

1. George ML; Lean Six Sigma for Service: How to Use Lean Speed and Six Sigma Quality to Improve Services and Transactions; McGraw Hill Professional, 2003
2. Schweikhart SA, Dembe AE; The Applicability of Lean and Six Sigma Techniques to Clinical and Translational Research; J Investig Med, 57 (7), 748 – 755, 2009
3. Pope D; Lean Six Sigma in the Clinical Trial industry: Two Perspectives; Applied Clin Trials, posted 09 October 2012: http://www.appliedclinicaltrialsonline.com/appliedclinicaltrials/article/articleDetail.jsp?id=791938
4. Wilson PF et al.; Root Cause Analysis: A Tool for Total Quality Management; ASQ Quality Press; 1993
5. Allies in Lean Six Sigma: What Lilly and Covance Have Learned. Pharma Qbd, posted 22 June 2010: http://www.pharmaqbd.com/allies_lean_lilly_covance/
6. Goldfarb NM; Accelerating the Process of Negotiating Clinical trial Agreements; J Clin Res Best Practices; 2 (10), 1 – 9, 2006
7. Francois Marti; Lean Six Sigma Method in Phase 1 Clinical Trials: A Practical Example; Qual Assur J; 9, 35 – 39, 2005
8. Manage projects – RACI, posted October 2014: http://www.manageprojectsonsharepoint.com/wp-content/uploads/2014/10/RACI.jpg

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Volker Hack is senior director of project management at PPD. Contact him at +49 721 9184 144 or at volker.hack@ppdi.com.
Laura Bowers is a graduate intern, Pharm.D., candidate at PPD. Contact her at +1 828 218 0814 or at laura.bowers@ppdi.com.