Case Study 3
From Chaos to Control – 63% Reduction in Late/Replan Tasks in Just 4 Months
Profile
A global Class II medical device launch program with chronic execution delays and fragmented R&D handoffs across Engineering, Quality, Regulatory and NPI teams.
Challenge
The program faced a sharp rise in late and re-planned project tasks, peaking at over 325 issues in a single month.
Root causes included:
- Inconsistent program planning
- Ineffective cross-functional reviews
- Delayed design verification and validation due to hidden quality and NPI bottlenecks
Approach
Directly embed with project and functional leads to deliver an integrated program management and quality operations recovery plan:
- Introduced LEAN program management principles for real-time visibility and early risk mitigation
- Re-designed design control gates to align Quality (QE, DQE, OQE) with NPI schedules and resource planning
- Implemented monthly operating reviews with functional KPIs and task accountability
Results
- 63% decrease in total late/replan tasks within 4 months
- Permitted to address resource bottlenecks using factual information
- Reduced execution volatility across NPI, R&D, Regulatory and Quality engineering teams
- Improved cross-functional alignment and program delivery predictability
Why It Matters
This improvement didn’t just fix symptoms. It built sustainable execution muscle across the organizational value chain; critical for regulatory success and meeting launch timeline expectations.
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