Alexion Pharmaceuticals

Case Study 2 – Quality Control

Key Challenges

Another team member at Alexion identified an issue regarding the “release” samples in the Quality Control Laboratory to Certificate of Analysis and wanted to reduce the lead time of this. This would ensure the they always have sufficient product in stock.

After training and mentoring, the team employed Value Stream Mapping, brainstorming, 5S, Kanban and Standard Work to analyse the problem.  One of the key outcomes of this project was that the team released a batch within the agreed target timeframe.  Most importantly, this was the fastest ever sample released from Quality Control. 

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 products

Key Actions

As part of the Root Cause Analysis, we held a Kaizen event.  We invited team members to brainstorm and “silently share” their ideas.  Next, the team presented the problem statement and supporting data.  Then, we collated and recorded all ideas.  A Kaizen event is a team brainstorming workshop.  It has a specific goal to improve a business process and minimise waste within a department or company.  Through “silent sharing”, we encourage all participants to think, reflect and share their ideas on post-it notes. 

Subsequently, we put all these ideas on an Impact/Ease Chart.  We 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.

Some of the findings from the brainstorming session included the following.

  • First of all, the team had spent up to one hour searching for samples.
  • Secondly, there was no segregation between the products.
  • Furthermore, there was no segregation between tests.
  • Finally, there was no segregation between testing status.

5S and Kanban

Consequently, the company implemented 5S in the sample fridges.  5S Workplace Organisation is the principle of waste elimination in a business.  It is derived from the Japanese words seiri, seiton, seiso, seiketsu and shitsuke.  This can can be translated as sort, straighten, scrub, systematise and standardise.  As a result, this made it easy to find samples for testing.  

In addition, they introduced Kanban for glassware.  Kanban & Pull Systems use a signal to trigger the movement, production or supply of a unit of material or information.  It is a workflow management tool designed to assist in visualising work, maximising efficiency and being agile.  This meant that the glassware was available when needed.  As a result, this ensured there was no need to search or wash glassware.  

Key Outcomes

There are further plans to implement 5S throughout the laboratory, not just the sample fridges.

When the team saw improvements, they were encouraged to get involved to keep the momentum going.


  1. Team involvement was essential.
  2. Kaizen alone can’t figure out what’s wrong.
  3. Implementing 5S – it cannot be kept up if the team is not invested.


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 Quality Control.  You may be interested in reading the two other case studies featured here: Case Study 1 – Packaging Materials and Case Study 3 – Regulatory Artwork.  All our case studies are available here.