Alexion Pharmaceuticals: Regulatory artwork adopted globally
A Lean project targeting artwork approval timelines delivered an immediate impact — and was adopted into the Continuous Improvement model for global NPI teams.
Pharmaceutical / Biopharmaceutical
Lean Essentials
Blanchardstown, Dublin
74% → 100%
Target for on-time artwork approvals
15 days
Target cycle time for artwork approval
Global
Adopted into CI model for NPI teams worldwide
Only 74% of regulatory artworks approved on time
An employee in Alexion’s regulatory affairs team identified that the artwork approval process was significantly underperforming. Based on data from the artwork management system, only 74% of regulatory artworks were approved on time — against a target of less than 4 days.
Furthermore, only 71% of artworks were approved first time, meaning an additional 90 artwork cycles were needed to correct and resubmit rejected work. This had cascading effects:
- Delayed artwork approvals constrained new product launch timelines
- Additional rework cycles consumed regulatory team capacity
- Planning and purchasing power was reduced by unpredictable approval timelines
- The process was not aligned across global markets
The employee saw an opportunity to implement a 15-day cycle time target with artwork being right first time and 100% compliant — and to roll the improved process out to other global markets.
From inconsistent approvals to a global CI model
Key Challenges
The regulatory team needed to:
- Increase on-time approval from 74% toward 100%
- Improve first-time-right rate from 71% — eliminating rework cycles
- Establish a consistent 15-day cycle time for artwork approval
- Create a process that could be standardised and rolled out globally
- Align the artwork process with planning and quality requirements
The Lean Solution
The team ran a Kaizen event as part of a broader programme to understand the regulatory experience of interacting with the artwork management system:
- Gathered data from the artwork management system to quantify current performance
- Used silent sharing and brainstorming to surface ideas from across the regulatory team
- Prioritised improvements using an Impact/Ease chart
- Implemented countermeasures targeting both the approval workflow and the root causes of first-time rejection
- Proposed rollout to all regulatory designees globally
8-Step Problem-Solving Process
The Kaizen event formed part of a larger programme of improvement events focused on understanding and improving the regulatory experience with the artwork management system.
Problem
Only 74% of regulatory artworks approved on time. 71% approved first time — creating 90 unnecessary rework cycles.
Current State
Analysed artwork management system data for 2017. Identified approval delays and first-time-right failures as key waste areas.
Target
15-day cycle time. 100% on-time approval. Artwork right first time and fully compliant.
Root Cause
Kaizen event using silent sharing and brainstorming. Identified inconsistent requirements and rework loops as root causes.
Countermeasures
Standardised requirements, improved first-time-right processes, aligned artwork workflow with planning and quality.
Implementation
Changes implemented with immediate impact. Proposed rollout to all regulatory designees globally.
Evaluation
Immediate impact on approval timelines. Adopted into the Continuous Improvement model for NPI teams.
Standardisation
Process adopted into CI model. Plan in place for US team implementation and rollout to other global markets.
Immediate impact and global adoption
The project delivered results at two levels — immediate operational improvement and strategic organisational change:
- Immediate impact on approval timelines. The countermeasures produced a measurable improvement in on-time artwork approvals from the first implementation cycle.
- Adopted into the Continuous Improvement model. The approach was so effective that it was formally adopted into the CI model for New Product Introduction (NPI) teams, aligning with both planning and quality functions.
- Global rollout planned. Alexion put a plan in place to implement the improved process with the US team and subsequently roll it out to other global markets.
- First-time-right improvement. By addressing the root causes of artwork rejection, the team reduced the number of unnecessary rework cycles — freeing up regulatory capacity.
Learnings
- Data from existing systems (the artwork management system) provided the evidence needed to define the problem precisely and measure improvement — you don’t always need new tools to get visibility.
- A Lean project in one region can become a global standard if the results are compelling and the process is well-documented.
- Regulatory and compliance processes respond well to Lean methodology — the perception that they’re “fixed” or “non-negotiable” often prevents teams from looking for improvement opportunities.
- Aligning improvement work with existing strategic initiatives (NPI, CI model) increases the likelihood of adoption and sustainability.
From local project to global standard
What started as a single employee’s improvement project became part of Alexion’s global Continuous Improvement model. That progression — from local insight to global standard — is exactly what Lean methodology enables when it’s embedded in an organisation’s culture rather than treated as a one-off exercise.
LeanTeams has worked with Alexion Pharmaceuticals since 2018. You may also be interested in: Case Study 1 – Packaging Materials and Case Study 2 – Quality Control. All our case studies are available here.
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