The Operating Model
A disciplined 6-stage implementation model for reducing Cost of Poor Quality (COPQ) in pharmaceutical manufacturing.
We own implementation alongside site leadership to correct structural execution friction and restore execution stability in 90–120 days.
The GMPKit Operating Model
Six stages work together to move a site from COPQ diagnosis through implementation and into sustained governance.
Stages 1–4 run sequentially. Stages 5–6 sustain gains and accelerate repeatable execution.
Sequential Execution: Stages 1–4
The first four stages execute in sequence to build a stable foundation for execution. Each stage delivers specific outcomes that enable the next:
Stage 1: Operational Diagnostics
We work with site leadership to 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 COPQ reduction.
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: Visibility & Control
We strengthen visibility and control to reinforce governance—so signals surface earlier, decisions move faster, and execution remains stable under pressure. Tools may vary; discipline does not. Where appropriate, BatchTrak™ provides the digital visibility layer.
Outcome: Earlier signals and tighter control that accelerate decisions and sustain governance discipline.
Sustainment: Stages 5–6
Stage 5: Rapid Response Support
When new disruptions emerge, we apply the operating model to protect stability without restarting the system.
Outcome: Disruptions are contained quickly without destabilizing the governance system.
Stage 6: Playbooks & Capability
We codify repeatable solutions into playbooks so teams execute faster, with less reliance on external support.
Outcome: Teams execute faster and more independently, reducing reliance on external support over time.
Flexible Engagement Options
Rapid Stabilization Engagement
For time-sensitive situations, we can engage at the stage you need most—diagnostics, implementation, or governance reinforcement. We mobilize experienced teams within days.
Ideal for multi-site organizations, CDMOs with inspection findings, or scale-up operations requiring immediate stabilization.
Leverage Our Playbooks
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 Reduce COPQ?
Start with a diagnostic call to identify where COPQ is generated and what to correct first — or use the COPQ Calculator to quantify the financial impact before we speak.