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Six Sigma, originally developed at Motorola in the mid-1980s, aims to improve quality and efficiency of processes by reducing variability and error. Adding in the principles of lean manufacturing has created Lean Six Sigma, which has a focus on eliminating waste as a way to improve outcomes.

So – what does Lean Six Sigma have to do with health? While it was developed as a manufacturing tool, Lean Six Sigma can be applied to many areas that deliver services through standardized processes. This includes the NHS, which can be likened to a production line, where patients enter the system at one 'end', receive treatment (whether acute or chronic) and are then discharged at the other.

Lean Six Sigma: Capabilities in change management
At Quintiles, we define Lean Six Sigma as change management through stakeholder engagement and data analysis that is focused on eliminating waste and improving outcomes through collaborative design, improvements and efficiencies of services and processes. We also see Lean Six Sigma and its tools and pathway modeling as a way to minimize the risk of error, and their application helps us both as an organization, and as a change management partner.

Stakeholder engagement
Lean Six Sigma is a collaborative approach, so stakeholder engagement is an important first step, particularly with the people who will be delivering the service. These are the individuals who will have the best grasp on the challenges and obstacles in the existing systems, and how they can be improved. They will also be the ones who are best placed to implement the changes. People who are unfamiliar to it may perceive the Lean Six Sigma language as jargon, so training and communication should be delivered in terms that are already in everyday use.

One of the steps used in Lean Six Sigma change management is a structured workshop (also known as a kaizen event), which may be at the beginning of the project to kick-start the process, or halfway through to evaluate the implementation steps. By taking stakeholders (for example patients, nurses, doctors and other members of the healthcare team, such as admin staff) away from their usual environment and giving them space and time, they can map out the process, identify the obstacles and challenges, point out the places where things could be improved, and suggest changes. The Quintiles service redesign team then works to create a localized practical solution that benefits patients and healthcare professionals and meets biopharma objectives, often through small and simple changes that can have a major impact. The biopharma companies that are funding the process may also be involved.

Data analysis
Data analysis is a vital part of the Lean Six Sigma process, and relies on good baseline information collected at the beginning, such as from time and motion studies. This allows the change management team to demonstrate to the stakeholders what difference each individual change has made. Simulation modeling is also important at this stage, as it can be used in scenario planning, including predicting what difference each change makes.

Case study examples of outcomes from Lean Six Sigma changes
Changes based on the Lean Six Sigma process aren't always major – often they are small in the context of a broader project, but can make a major difference to the overall efficiency and effectiveness of a service. The following are examples of the kind of small changes made by collaborative teams across a variety of different settings that have led to savings of time or money, or simply just made systems work better:

Overproduction
A hospital clinic had become overloaded, leading to a two-week wait for urgent referral. This was because GPs wanted patients seen as quickly as possible, so used the urgent referral system rather than the standard referral system. This meant that neither system worked properly. Lean Six Sigma techniques were able to recreate the patient pathway, ensuring that all patients were seen in an appropriate timeframe, and regaining the confidence of the GPs in the system.

Inventory
In a chemotherapy suite, the booking system had become very inefficient, as appointments were recorded in both electronic and paper diaries. This created issues with scheduling. Engaging the staff in the change process ensured that the electronic diary was used, reducing conflicts.

Motion
The furniture layout and provision in an outpatient clinic was not optimal for patient interaction and treatment, and the consultant requested a complete refitting of the consultation room. After analysis of a time and motion study, it was realized that adding just one small piece of furniture would improve the setup, reducing costs and avoiding major disruption.

Defects
A lung oncology team was unable to enter diagnoses and treatment decisions into the medical records system because of missing details of specific consultants. By ensuring that certain fields were mandatory, the system became a lot more usable.

The impact on NHS services
While delivering healthcare clearly is not exactly the same as manufacturing products, taking Lean Six Sigma approaches to tackle 'waste', whether it is in terms of time, costs, delivery or patient outcomes, has potential to have a positive effect on the NHS.

Topics in this blog post: Biopharma, Oncology, Market Access, EU, NHS