Alexion Pharmaceuticals

Case Study 1 – Packaging Materials

Key Challenges

We worked on a particular Lean project with one of their employees.  This related to the lead-time reduction of packaging materials.  To start with, the standard lead time for creating new packaging materials was greater than 3 weeks.  On average, this was 46 days.  Materials are expedited and arrive on site within 10 days.  The target was to reduce lead-time to less than 2 weeks for all packaging materials.

Following completion of the Lean Business Tools training programme, the company streamlined a new form.  In addition, they created a new online workflow.  As a result of this employee’s project, Alexion Pharmaceuticals reduced this lead time to 10 days.  This represents a 78% reduction.

Every day, those who live with rare diseases and devastating conditions inspire us to push the boundaries of medicine, technology, and healthcare services.  Our goal is to transform their reality for the better.

8-Step Problem-Solving Process

In trying to solve a particular problem, we advise using the 8-Step Problem-Solving Process:

  1. Problem
  2. Current State
  3. Target
  4. Root Cause Analysis
  5. Select Countermeasures
  6. Implementation
  7. Evaluation
  8. Standardisation & Learnings
Alexion Pharmaceuticals College Park

Key Actions

As part of the Root Cause Analysis, we organised a Kaizen event with the team.  Firstly, we invited representatives from Purchasing, Quality Control, Warehousing and Finance to brainstorm and “silently share” their ideas.  Next, the team presented the problem statement and supporting data.  Then, they collated and recorded all ideas.

Finally, we put all these ideas on an Impact/Ease Chart.   Above all, we wanted to assess the potential impact or benefits they will have on the company.  The result is a visual representation of where best to assign time and resources.  We don’t discard any issues.  Their assessment may change over time as other problems are resolved.  Therefore, we can summarise these four activities as follows:

  1. Just Do It – these ideas have high impact and are easy to do now.
  2. Why Not? – these issues have low impact and are easy to address.
  3. Projects – ideas that have high impact but are difficult to address.
  4. Not Now – issues that have low impact and are also difficult to address.


  • To start with, the team members identified time as a waste.  They were spending too much time waiting on signatures for the material creation form.
  • Next, they developed a streamlined workflow by eliminating non-value added activities.
  • In addition, they introduced a new document workflow. For example, all functions can complete their updates independently. There was no waiting on the form to “arrive” before completing an update.
  • Furthermore, the company developed a report.  This would allow for materials to be checked for completeness prior to arriving on site.
  • The team streamlined a new packaging form with QA and OPs approval signature removed.
  • Subsequently, the company ensured that all required information is on the form.  For instance, vendor details, batch classification etc.
  • Finally, they uploaded the template form to online document workflow for development.

Key Outcomes

SMED Critical Window

SMED (Single Minute Exchange of Dies) is a Lean tool.  It reduces the amount of time it takes to change from running one process in an operation to another.  This rapid changeover is key to reducing batch sizes and improving workflow.

  • The online document approval workflow allows for new material creation forms to be routed in parallel.
  • Next, they created a quality master data which was incorporated into the basic material master data set up.
  • Consequently, this eliminated risk from further down the supply chain.


Standard Work is a very powerful but under-utilised Lean tool.  By documenting the current work practices, this sets the base standard for what can be improved within the company.  As continuous improvements are made, the new standard of work becomes the base for future changes.

  • The new online workflow now allows for greater visibility of where each material is within the creation process. This makes it easier to develop KPIs and metrics to help drive future improvements.
  • In addition, the company has put in place a Work Instruction for developing inbound deliveries reports. This is run on a weekly basis to eliminate non-conformance.

We needed to look at several solutions to the problem.  For example, don’t focus on the first solution that arises.

Alexion Pharmaceuticals Lean Case Study on Laboratory Packaging Materials


  • The supporting data is fundamental to getting the problem resolved. People need to be able to quantify the problem.
  • Value Stream Mapping is extremely effective in highlighting waste within the system.
  • Sometimes, people are just waiting for a solution to be proposed.


We firmly believe that the expertise to develop business process improvements already exist in every organisation.  This has clearly been the case in Alexion Pharmaceuticals.  Through their employees’ Lean projects, the company has made significant continuous improvements to their business.

ETAC has worked with Alexion Pharmaceuticals to streamline their business and improve their processes.  We hope you enjoyed reading about this case study on Packaging Materials.  You may be interested in reading the two other case studies featured here.  Case Study 2 – Quality Control and Case Study 3 – Regulatory Artwork.  All our case studies are available here.