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PHARMA AND BIOTECH

PHARMA & BIOTECH


The EFESO Pharma & Labs practice is the global leader in the provision of Real Lean Transformation© services to Life Science Companies. ​

The practice significantly increased its presence and capability via the acquisition of BSM.  For more than15 years BSM was well known in the Pharma and Biotech sectors for its expertise in the implementation of ‘Real Lean’ techniques which often receive insufficient attention in Operational Excellence programs. BSM’s hands-on and low-hype approach, combined with EFESO’s global reach, ability to provide local language support and obsession for progression excellence makes EFESO’s Pharma & Biotech experts the ideal partners to support your progression journey.

We are a highly-motivated team with deep sectoral knowledge and a passion for improving processes and performance. We really know Lean and we really know Pharma & Biotech.

We have an unrivalled track record in the achievement of significant and sustained performance improvements across Pharma & Biotech operations and quality functions. The EFESO Pharma & Labs practice has or is currently supporting programs with 8 of the top 10 global Life Science companies.​

We work with clients to achieve truly Lean standards of performance in Quality, Velocity and Productivity by implementing the long-established, but little understood Real Lean principles of Levelling, Flow and Standard Work in Manufacturing and Laboratory environments.

Our aim is to deliver sustainable step change on a scale that generic Lean / Sigma techniques and simple loss reduction cannot achieve.

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NEWS ABOUT THE PHARMA & BIOTECH INDUSTRY


  • Breaking Barriers In Pharma

    Lean and Operational Excellence in Pharmaceuticals The pharmaceutical sector is very different from the short cycle manufacturing environment that Lean was originally developed for (i.e.…

FOCUS AREAS FOR THE PHARMA & BIOTECH INDUSTRY


  • We provide a deep knowledge and practical application of Real Lean and Operational Excellence concepts in Laboratory and QA environments that provide significant business value in a short period of time.

    Our focus is on developing a ‘system of operations’ and processes that result in Leveling of short interval workloads, reduction of throughput times (i.e. creation of  Flow) and support an appropriate level of standardization of tasks (i.e. Standard Work) . These new processes are supported by visual management based Short Interval Control and Performance Management processes  


    The benefits of our approach

    01

    Defined, structured and controlled processes delivering more consistent and predicable performance​

    02

    Significantly Increased productivity ​

    03

    Improved RFT (Right First Time) ​of 15 % to 30% after the first 2-3 months

    04

    Reduced throughput-times​

    05

    Reduced Unit Costs​ via H/C reduction, H/C avoidance, or increased throughput

    06

    Reduced levels of WIP and associated Management effort ​

    07

    ​Greater empowerment of Operating Personnel​

    08

    ​A culture of engagement and pro-active performance management and continuous improvement​

    09

    Internalisation of Skills and Knowledge

    These issues usually result in long and inconsistent lead-times and/or high costs.


    The EFESO Pharma & Labs practice are experts in applying ‘Real Lean’ in Labs and QA functions and have developed innovative methodologies and solutions specific to the Pharma and Biotech Quality function environment. ​

    Many weaker Lean initiatives are based almost totally on waste elimination and the application of easy to understand tools like 5S, Value Stream Mapping and Kaizen. While these methods will certainly yield some results we know that more significant and sustainable gains will be realized by also applying the deeper Real Lean concepts of leveling, flow, pull and standard work.​


    Labs and QA functions are not the same as manufacturing:​

    • Workload and Mix Volatility - There is typically more workload and mix volatility (i..e the mix and volume of samples varies significantly day to day and week to week.​
    • Complex mix of Routine and Non Routine Testing - There is often a complex mix of routine and non routine testing, other tasks and project work.​

     

  • The EFESO Pharma & Labs Practice has shown that ‘Real Lean’ practices can help RA Organisations to provide a better Quality service and also deliver exceptional improvements in Productivity and Leadtime.

    Historically the focus within Regulatory Affairs (RA) processes has very much been on compliance and “getting the job done whatever the cost”, with little or no focus on Lean best practices and the improvements in speed, productivity and reliability that Lean can deliver.

    The opportunity to apply Real Lean in Regulatory Affairs (RA) is not intuitively obvious, because RA activities are project-based with workloads which are both variable and unpredictable.

    The EFESO Pharma & Labs Practice has shown that ‘Real Lean’ practices can help RA Organisations to provide a better Quality service and also deliver exceptional improvements in Productivity and Leadtime. This applies to the full spectrum of regulatory activities from strategy / content contribution, the associated manage and build activities, through to publishing and archiving.​


    What we often find in RA Processes

    01

    Workload volatility​ and over resourcing to cope with peak workloads​

    02

    Insufficient visibility of open projects and future workload constraints​

    03

    Overly complex and inefficient planning & scheduling processes ​

    04

    Poor process harmonization across sites​

    05

    Poor process definition and role responsibility​

    06

    Reliance on expensive outsourcing​

    07

    Significant undocumented “Tribal” knowledge​

    08

    Product specific personnel dedication​

    09

    Long delays between work elements – “forget and re-learn”


    Our solutions are built on the Real Lean principles of Levelling​, Flow, Standard Work and Visual Management (with or without software tools)​​.

    The results are typically as follows​:

    • Significantly Improved Productivity -  typically  by up to 100 % and sometimes more
    • Improved Quality – typically a 40-50% reduction in quality issues​
    • Improved Compliance – reduced audit observations and reportable events​
    • Improved Speed - Improved Project Speed and reduced task cycle times.​
    • Improved visibility - Significantly improved visibility of workloads and the ability to make accurate ‘commit dates’ to the business ​

     

  • WCOM & HD best practice is used to reduce losses and waste and improve consistency of performance.

    Our Real Lean & WCOM approach shifts the focus of improvement initiatives from individual wastes or activities to the flow of batches through the total manufacturing process.

    It uses ‘leveling’ techniques to address short interval volatility in overall workload and operator effort and generates flow by creating ‘defined sequences’ of activity that flow batches quickly through all required process stages.

    The defined sequences are also used to time separate tasks that are labor dependent   ​
    Production tasks can then be combined into balanced, productive, repeatable operator roles that use people’s time well (standard work).​

    WCOM & HD best practice is used to reduce losses and waste and improve consistency of performance.

    This approach generates significant productivity & performance improvements and helps improve RFT and compliance.


    The benefits of our approach

    01

    Defined, structured and controlled processes delivering more consistent and predicable performance​

    02

    Significantly Increased productivity ​

    03

    Improved RFT (Right First Time) ​of 10 % to 20% after the first 2-3 months ​

    04

    Reduced throughput-times​

    05

    Reduced Unit Costs​ via H/C reduction, H/C avoidance and reduction of safety stocks

    06

    Reduced levels of WIP and associated Management effort ​

    07

    ​Greater empowerment of Operating Personnel​

    08

    A culture of engagement and pro-active performance management and continuous improvement​

    09

    ​ Internalisation of Lean and WCOM Skills and Knowledge


     

  • The reality is that the work profile in each lab will consist of a combination of (somewhat) routine activity & analysis and more creative & interpretative type tasks. Applying Real Lean principles will improve the productivity, speed and consistency of the more routine elements thereby providing more time and resources for the more creative and interpretative tasks.

    One might wonder if Lean and Operational excellence principles have any relevance in R&D labs, after all, R&D labs are significantly different from other types of laboratories. In fact R&D labs are significantly different from each other. There’s such a broad range of categories, from labs that support an R&D function with test results, to labs that develop new test methods for new products, to labs that are trying to synthesize new molecules, and on and on.​

    With such a broad range of laboratory types do the principles of Real Lean, namely Levelling, Flow, Standard Work, Short Interval Control and Performance Management, still apply? ​

    The reality is that the work profile in each lab will consist of a combination of (somewhat) routine activity & analysis and more creative & interpretative type tasks. Applying Real Lean principles will improve the productivity, speed and consistency of the more routine elements thereby providing more time and resources for the more creative and interpretative tasks.

    Work within R&D labs is usually project based. As projects move through the various stages and cycles of their lifespan they generate vastly different amounts of work for the lab. These peaks and dips in workload make it extremely difficult to be predictable, consistent, productive or fast. The extreme nature of these peaks and dips also exacerbate some of the Common practices we find in R&D labs.​


    What we often find in R&D labs

    01

    Project based work leading to intense peaks and dips in workload depending on the project stage or cycle​

    02

    Resources dedicated by project – meaning volatile project workloads are imported directly onto scientists​

    03

    Constant changes in priorities leading to stop-start-stop projects, frustration for scientists and extremely long lead times

    04

    No Flow, No metrics or performance goals

    05

    No visibility on overall workload

    06

    No visibility on individual resource workload​

    07

    No understanding of what the true capacity of the lab is

    08

    ​Poor or no resource management – meaning when one project peaks a scientist can be overwhelmed while another colleague is almost unoccupied

    09

    Delays around report writing and no common format for data reporting​

    These issues limit the time available for true innovation because most time is spent tracking, finding, communicating, prioritizing, planning and testing common samples.​


    Successfully applying Real Lean principles in an R&D setting can be massively beneficial. In fact some of the largest Lab performance improvements EFESO Pharma and Labs practice have overseen have been in R&D labs, for example:

    • 400% increase in capacity​
    • 74% reduction in cycle time​
    • Freeing more than 25% of the resources from routine work allowing them to focus exclusively on novel discovery work.​

     


Want to know more about our tooling?

Watch the Touch Screen Visual Management Tool video

OUR REFERENTS FOR PHARMA & BIOTECH


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