Real Lean Blogs

The challenges facing Quality Assurance Teams in Cell Based Therapy Companies

The challenges facing Quality Assurance Teams in Cell Based Therapy Companies. Optimizing Quality Assurance for Cell-Based Therapies: Meeting Unique Challenges with Real-Time Review and Lean Solutions for Quality Assurance in Personalized Medicine.

Lab Excellence for CAR-T Cell Therapy

How does Lean Lab apply in the era of personalized therapeutics? Adopting Lean Lab Principles for Personalized Therapeutics: Meeting the Need for Speed, Quality, and Scalability in Cell-Based Therapies

Lab Excellence for CAR-T Cell Therapy

How does Lean Lab apply in the era of personalized therapeutics? Adopting Lean Lab Principles for Personalized Therapeutics: Meeting the Need for Speed, Quality, and Scalability in Cell-Based Therapies

Lean & Operational Excellence in Life Science CDMO’s (part 1)

Unleashing Efficiency in Pharma & Biotech CDMOs: Discover how leveling, flow, and standard work can transform CDMO labs, optimize resources, and boost productivity for sustainable growth.

This is part one of a three part series of short articles on Lean and Operational Excellence challenges in the CDMO sector.

Three Ways Lean Lab Projects Create an Empowered Workforce And Why That’s Important

By engaging employees while implementing Lean principles, companies create a culture of accountability, collaboration, and motivation. The positive outcomes of this drives employee empowerment in three key ways. Ultimately, employee engagement in Lean Lab projects leads to a more empowered and invested workforce, that benefits the overall success of the company.

The importance of ‘triage’ in variable effort work packages in quality control teams

Teams with high variability in incoming workload, face significant challenges in trying to organize their work in a fast productive manner. A quick controlled Triage process can boost performance without overloading team resources.

Five Ways Lean Lab can help you become a Greener Lab

Improving the environmental impact of the lab might not be the initial goal of a Lean Lab project but it can be a beneficial outcome without any extra effort or expenditure.

Are Dedicated Paperwork Reviewers a good idea for your QC Lab?

In labs, testing often takes priority while the review is somewhat of an afterthought. However, it is important to realise that until the results are reviewed and approved, we should not consider a test to be completed. There are several reasons why review may not be completed promptly, including volatile incoming workloads and changing/competing priorities.

Structured Problem Solving – The key to Lean?

Companies that have successfully implemented Lean understand that the “Stability” or foundation the House of Lean is built upon is Structured Problem Solving. The iterative improvement loop offered by Structured Problem Solving allows for the correct Lean tools to be used at the correct time and in the correct way.

Understanding Lean Lab for Operations Excellence Teams

Service level is a key deliverable in any lean lab project, and the business will not tolerate poor lead time performance in order to deliver benefits elsewhere.

When designing lean lab solutions, a key design target is to be as productive as possible, while delivering consistently against the lead time targets of the business.    

Improving Laboratory Productivity after Workload Increases

Has your QC Lab grown naturally over a period of time from a small lab into a bigger lab due to a growth in business demand? Are your employees under a lot of stress with never ending emails and phone calls from production and supply chain looking for sample approval? This expansion in activity is great news for the business but is most likely causing operational problems in your lab.

The Importance of Visual Management in a Lean Laboratory

A Laboratory is usually a busy environment with many different activities simultaneously in progress. Having a good understanding of what is happening with each sample and test, or at least having quick access to that information is essential to the smooth running of that lab. Consequently, the importance of good, effective and up to date Visual Management cannot be overstated.

Surge Capacity in Labs

One of the key goals of ‘Lean Lab’ is to create lab processes that operate and are resourced at the ‘levelled demand rate’. This enables the Lab to efficiently and productively meet the needs of the business.

3 Important Questions to Consider when Designing Labs with Lean in Mind

Building (or refurbishing) laboratories is a costly and time-consuming activity for a company. Poorly designed spaces can be costly in terms of lost productivity, slower turn around times and higher inventory of equipment and consumables.

Project Based Labs

Laboratories with project based workloads often have greater volatility in both the volume and mix of work than other lab types. The work content of later steps may only be clear after the preceding step is complete.  This all adds to an inherently unpredictable workload, both for the overall lab and for individual personnel. But there are some core strategies that you can deploy to make project labs more productive.

The Seven Deadly Sins of Lean Programmes - Why Lean Programmes often under perform

In an effort to deploy Lean across their organisations, many companies have invested heavily in large multi site programmes supported by dedicated internal Lean resources. The results from these programmes are quite often patchy and underwhelming. So why do these programs under perform?

Raw Materials / Consumables Laboratories – Understanding the Nuances and a Strategy to Ensure Best in Class Performance

Raw materials / consumables labs are integral to the smooth and stable operation of a production plant and as such they perform a very important function. The cardinal sin for an incoming materials laboratory is to cause a change in the production schedule due to a material not being released on time. While most plants will try to have some sort of fixed production schedule, production environments are inherently fluidic and dynamic in nature. This fluidity can negatively impact the lab; often leading to constant prioritization and re-prioritization cycles of materials to be tested in the laboratory. This means that a lot of unnecessary non value-add effort is expended on scheduling. The net effect of all of this is a pressurized environment where analysts feel that they are in constant firefighting mode.

Waste in Laboratories

Laboratories are not the same as manufacturing environments so do the standard Lean ‘Wastes’ even apply in Labs? BSM can show you the "right" wastes to tackle to unlock the performance of your testing laboratory.

Lean Tools versus Lean Systems

Since the emergence of the Toyota Production System (TPS) in the early nineties there have been many successful introductions of Lean manufacturing to all types of differing industries from Healthcare to Retail. Providing Lean consulting services has become big business. But without understanding the deeper principles behind Lean, companies can be too focused on the application of Lean Tools instead of deploying Lean as a holistic system. “Managers are struggling to combine lean techniques into a coherent system.” (Womack & Jones, Beyond Toyota: How to Root Out Waste and Persue Perfection, 1996)

Bringing Flow to the Review and Release Process

The concept of flow is a key element in achieving lean operations. This fact has not gone unnoticed by laboratories but many still struggle to achieve real flow and very often the final review and release of samples can prove to be somewhat of a bottle neck. The final review and release tasks should not be thought of as being autonomous or decoupled from the testing process and should be incorporated in the flowed process.

The Trouble with Dedicated Resources: Leveling the Workload

Dedication of resources may seem like a good way to have “Subject Matter Experts” (SMEs) get through work quickly, but it gives rise to a costly productivity penalty. The antidote is to level the workload across the team (without compromising the important role of the SME!).

Three Ways our Batch Records set us up for Failure (and how to address them!)

One of the ways we can improve Batch Record Right First Time (RFT), and hence throughput time, is by improving the Batch Record design.  By reengineering the document we can reduce the opportunities to make errors.  Batch Record (BR) redesign is an important part of a Lean QA (Lean in Quality Assurance) project, because it not only addresses RFT and throughput time, but it also leads to a reduced review effort (and hence workload) for manufacturing and QA reviewers.

Optimising QC Lab Testing

QC test methods and the overall testing approach employed in laboratories can themselves be inherently wasteful. What steps should be taken to identify and eliminate such waste?

Why can't my department get ahead and be productive

In operations where the short interval (e.g. daily or weekly) workload varies, the most common method of distributing the work is to share it equally between the available people. We call this method “available work through available people”. The consequence of this approach is that even low daily workloads expand to fill the day resulting in poor productivity. Carefully designed standard work can improve your department’s performance by consistently making the most out of people’s time.

Can and should Lean be applied in Labs?

Lean originated in the automotive industry and it’s easy to see how the tools and concepts are a good fit for that type of manufacturing. It’s much less obvious however that Lean can and should be applied in Labs.  In recent times Lean Lab projects have become quite common but…

Is Lean really an appropriate strategy in the Lab environment or are labs just blindly following trends?