Alexion Pharmaceuticals

Case Study 3 – Regulatory Artwork

Key Challenges

We worked with a team member on their Lean project regarding regulatory artwork approval time.  Actually, the timeline should be in alignment with the process of ≤4 days. However, based on available data from the artwork management system for 2017, only 74% of regulatory artworks were approved on time.  Furthermore, 71% was approved first time.  This required an additional 90 artworks cycles.  By reducing the cycle time, this would improve planning opportunities and purchasing power. 

This employee saw an opportunity to implement a 15-day cycle time for artwork approval with the artwork being right first time and 100% compliant.  Most importantly, there was an opportunity to roll out this method to other markets.

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 product

Key Actions

A Kaizen event formed part of a larger program of events.  This came from an overall requirement in understanding the regulatory experience of interacting with the artwork management system.

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. 

Then, we put all these ideas on an Impact/Ease Chart 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 as 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.

Following the implementation of the above measures, the organisation proposed to roll the outcomes to all regulatory designees globally.

Alexion Pharmaceuticals machinery

Key Outcomes

This project had an immediate impact.  Above all, it has been adopted into the Continuous Improvement model for the NPI teams while also aligning with planning and quality.

Alexion Pharmaceuticals have put a plan in place to implement this project with the US team and roll it out to other global markets.


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 this case study on Regulatory Artwork.  You may be interested in reading the two other case studies featured here: Case Study 1 – Packaging Materials and Case Study 2 – Quality Control.  All our case studies are available here.