How We Work
When manufacturing networks fail, we execute rapid operational recovery in 90-120 days using a proven, disciplined operating model.
We use Cost of Poor Quality (COPQ) reduction as the lens to prioritize actions and measure results.
The GMPKit Operating Model
Our operating model integrates 6 stages that work together to restore operational stability in 90-120 days. Stages 1-4 execute sequentially, with each stage building on the previous one to create sustainable operational recovery.
All stages are unified by the COPQ lens—prioritizing actions that deliver the fastest reduction in Cost of Poor Quality.
Sequential Execution: Stages 1-4
The first four stages execute in sequence to build a stable foundation for operational recovery. Each stage delivers specific outcomes that enable the next:
- Stage 1 identifies operational gaps through diagnostics
- Stage 2 translates gaps into remediation plans with readiness criteria
- Stage 3 executes remediation through governance systems
- Stage 4 enables governance with digital visibility
Stage 1: Operational Diagnostics
We partner with your site teams to rapidly diagnose root causes of batch failures, deviation backlogs, and inspection findings. Using the COPQ lens, we quantify quality, operational, and decision/governance costs to prioritize actions.
Outcome: Clear understanding of where COPQ is generated and which interventions will deliver the fastest recovery.
Stage 2: Operational Readiness & Remediation
We translate diagnostic findings from Stage 1 into actionable remediation plans—building readiness criteria, sequencing gap closure, and applying proven playbooks for common problems like scale-up and inspection readiness. This stage bridges diagnostics to governance execution.
Outcome: Clear remediation plans with readiness criteria, prioritized sequencing, and proven playbooks—ready to feed into governance execution (Stage 3).
Stage 3: Governance Systems
We implement LEAN-based governance systems that convert strategy into disciplined execution. These systems ensure accountability, visibility, and continuous improvement—delivering planned, predictable batch flow that persists after we leave.
Outcome: Sustainable governance systems that maintain operational stability and prevent COPQ from returning.
Stage 4: Digital Visibility
We deploy digital tools (like BatchTrak™) to reinforce governance systems with real-time visibility and benchmarking. Digital is not a starting point—it's an enablement layer that makes governance systems more effective and scalable.
Outcome: Real-time operational visibility that enables faster decision-making and sustains governance discipline.
Ongoing Support: Stages 5-6
Stage 5: Rapid Response (Enterprise Clients)
When new crises emerge, we provide rapid response support to apply the operating model to evolving challenges. This ensures your team can handle unexpected events without losing operational stability.
Stage 6: Playbooks
We develop playbooks that codify proven solutions for recurring scenarios. These playbooks enable your teams to execute fast improvements independently, reducing reliance on external support.
Flexible Engagement Options
Rapid Deployment Service (Enterprise Clients)
For enterprise clients facing urgent crises, we offer a rapid deployment service that can engage at any stage of the operating model. Whether you need immediate diagnostics, governance implementation, or digital enablement, we mobilize experienced teams within days.
This service is ideal for multi-site organizations, CDMOs with inspection findings, or scale-up operations requiring immediate stabilization.
Leverage Our Playbooks
Clients can access our library of proven playbooks to execute fast improvements independently. These playbooks codify solutions for common scenarios like deviation backlog reduction, batch disposition acceleration, and inspection readiness.
Playbooks provide step-by-step guidance, templates, and decision frameworks—enabling your teams to apply GMPKit methodologies without full consulting engagement.
Ready to Restore Operational Stability?
Start with the COPQ Calculator to quantify your operational challenges, or schedule a discovery call to discuss how our operating model applies to your specific crisis.