11 September 2026

Sustaining Pharmaceutical Improvement at Scale

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The context

Eli Lilly’s Six Sigma deployment provides a concrete example of improvement becoming an organisational capability. By the end of 2006, the company reported deploying 400 Black Belts and 700 Green Belts across the business in its annual report. That scale creates a substantial programme management challenge: selecting worthwhile work, supplying capable leaders and keeping benefits visible after projects close.

This is an analysis of publicly documented company activity, with no connection to a Lean Six Sigma International client engagement. The deployment facts are attributed below. The phase structure and proposed governance arrangements are an interpretation for Master Black Belt trainees, because the sources do not publish a complete programme charter or governance manual.

The problem

A deployment can outgrow its original operating model. In a 2015 presentation, Lilly Master Black Belt Humberto DeLuca described shrinking Black Belt classes, rising training and travel costs, restricted Green Belt access and increasing demand for Master Black Belts.

The decision was practical: how could the organisation maintain project leadership capability while using scarce expert time effectively? More training places would only help if suitable projects, sponsors and coaching capacity were available. Equally, a portfolio full of attractive opportunities would remain stalled if the people assigned to them needed support that the programme could not provide.

How the belt scoped it

Lilly had connected Six Sigma to resource redeployment, research and development cycle time, customer interactions and earnings in its December 2005 investment community update. Those objectives provide a useful starting point for a business-unit deployment charter.

For a Master Black Belt, the scope would encompass the project pipeline, selection criteria, sponsor responsibilities, Black Belt development and benefits review. Individual teams would retain responsibility for their process investigations. The Master Black Belt would own the consistency of the improvement system and coach the people operating it.

A pharmaceutical manufacturing unit could bound that programme around production, laboratory testing and batch release. Quality assurance would participate in project selection and change decisions. Proposed changes affecting approved processes would enter the unit’s established change-control and validation arrangements, with those resource requirements included in the portfolio plan.

The tools applied phase by phase

Define: translate strategy into a manageable portfolio

A strategy deployment matrix would connect business objectives to candidate projects and accountable process owners. Selection would consider patient and supply risk, expected operational benefit, evidence availability, implementation difficulty and coaching demand.

The scale question was real. Lilly’s 2005 update set out plans for 1,600 new projects and 400 Black Belts in 2006. These were forward-looking plans. They create a useful review question: how much concurrent work could the supporting organisation actually absorb?

A portfolio board would examine dependencies before authorising starts. Several projects might all need the same validation engineer or laboratory specialist. A resource-loaded portfolio would expose that collision before it became a series of missed project milestones.

Decision Evidence reviewed Accountability
Select Strategic contribution, risk and available capacity Business sponsor and portfolio board
Advance Reliable baseline and supported causal explanation Black Belt, coached by Master Black Belt
Implement Pilot evidence and change requirements Process owner and quality assurance
Sustain Process stability, benefit evidence and ownership Process owner, finance and sponsor
Conceptual governance model for a pharmaceutical improvement portfolio, developed for this analysis.

Measure: establish two connected baselines

The proposed measurement plan would cover both project performance and deployment performance. Projects would have operational definitions for their outcomes. The programme would track elapsed time to project launch, delays at reviews, coaching hours, demonstrated competence and benefits awaiting verification.

For example, a batch-release project would need agreed start and finish events, segmentation by product family and visibility of waiting time. Its programme record would also show whether missing laboratory data or unavailable coaching was delaying the investigation. These measurements would help distinguish process constraints from deployment constraints.

Analyse: investigate the capability constraint

DeLuca’s presentation describes gathering input from alumni, business leaders and deployment colleagues. Their needs included flexibility, more practice and stronger team, project and change management.

A Master Black Belt could connect such feedback to project-review evidence. Repeated weak baselines would suggest measurement coaching needs. Repeated sponsor delays would suggest an ownership problem. These hypotheses would be tested against actual project histories before revising the curriculum.

Coaching would then focus on decisions: whether a measurement system is adequate, whether an apparent cause survives stratification, or whether pilot evidence supports expansion. A capability matrix would record demonstrated performance and identify where another coached application was needed.

Improve: redesign learning alongside project delivery

Lilly’s documented response combined self-paced study, classroom practice and testing, plus support and reviews, as shown in the blended-learning model.

Applied to the proposed business-unit programme, each trainee would enter with a screened project and a committed sponsor. Practice sessions would use relevant pharmaceutical process questions. Master Black Belt reviews would connect technical learning to the trainee’s current evidence and next decision.

A pilot would test the whole arrangement, including access to data and coaching. Failure mode and effects analysis could examine foreseeable breakdowns such as trainees advancing without prerequisite knowledge or projects reaching implementation without quality involvement.

Control: maintain capability and operational gains

The proposed control plan would give every completed project a process owner, monitoring method and response plan. Benefits reviews would distinguish realised expenditure reductions, released capacity and working-capital changes, with finance checking overlapping claims.

At programme level, periodic reviews would examine stalled projects, coaching demand and performance after handover. Replication across sites would include an assessment of local differences, followed by confirmation that the transferred method worked under those conditions.

What the result was

Lilly’s 2006 annual report stated that Six Sigma benefits exceeded its $250 million goal. This was a company-reported programme result; the cited passage does not provide project-level calculations.

The later curriculum presentation reported more than 90% agreement on opportunities to apply learning and confidence to lead a project in its evaluation slides. These are participant perceptions. They do not establish sustained process improvement, and the later training redesign cannot explain the earlier financial result.

What a trainee should take from it

A useful training assignment would be to defend a deployment plan under constrained coaching capacity. The deliverables would include a prioritised portfolio, resource assumptions, a Black Belt development plan and evidence requirements for closure. The difficult discussion comes when a sponsor wants another project started while existing teams are waiting for technical review. The trainee would need to show which commitment should move, who accepts the consequence and how the decision protects the business unit’s priorities.

Sources

Financial services
Healthcare
Logistics and supply chain
Manufacturing
Pharmaceuticals

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