Our process redesign work typically follows a three-phase methodology that balances compliance with operational performance.
Phase 1: Assess
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Map current-state workflows and identify bottlenecks, redundancies, and compliance risks
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Review regulatory requirements (e.g., FDA QSR/QMSR, ISO 13485, ICH Q10) to ensure alignment
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Benchmark performance (e.g., cycle time, error rates, resource burden)
Phase 2: Redesign
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Create optimized future-state workflows that eliminate waste and improve control
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Integrate risk-based checkpoints and simplify steps for better consistency and compliance
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Identify opportunities to automate, digitize, or standardize processes
Phase 3: Implement
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Plan and manage change with SOP updates, training, and phased rollouts
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Develop role-based training tools and deliver targeted sessions
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Pilot new processes, refine based on feedback, and monitor performance post-launch