Governance Systems
Design Routines That Sustain Improvement
We implement PDCA-structured LEAN governance systems that ensure disciplined execution and accountability—working with your existing structure, supplementing only where gaps exist.
The Governance Gap
Most pharmaceutical manufacturers struggle to sustain operational improvements because they lack the governance routines needed to maintain discipline, accountability, and continuous improvement.
Improvements Don't Stick
You implement changes, see initial results, then watch performance drift back to baseline within months because there's no governance system to sustain it.
Accountability Gaps
Teams lack clear ownership of performance metrics. When problems arise, there's no structured escalation path or decision-making authority.
Reactive, Not Proactive
Leadership only learns about problems after they've become crises. There's no early warning system or structured cadence for performance reviews.
PDCA-Structured LEAN Governance
Our governance framework is built on the Plan-Do-Check-Act cycle—a proven methodology for continuous improvement that ensures strategy execution happens with discipline and accountability.
Plan
Set clear objectives, define success metrics, and establish accountability for execution.
Do
Execute the plan with disciplined adherence to standard work and real-time problem-solving.
Check
Monitor performance against targets using structured reviews at daily, weekly, and monthly cadence.
Act
Take corrective action when performance deviates, standardize improvements, and continuously refine.
Structured Governance Cadence
We implement a tiered governance structure with daily, weekly, monthly, and quarterly reviews—ensuring problems are identified early and escalated appropriately.
Daily Tier Meetings
Daily (15-30 minutes)
Front-line supervisors, technicians, quality personnel
Focus Areas:
- Yesterday's performance vs. target
- Today's priorities and constraints
- Safety and quality issues
- Escalations to leadership
Weekly Operations Reviews
Weekly (60-90 minutes)
Site leadership, operations managers, quality managers
Focus Areas:
- Week-over-week performance trends
- Batch disposition status and aging
- Deviation backlog and investigation progress
- Resource constraints and bottlenecks
Monthly Executive Weigh-Ins
Monthly (90-120 minutes)
COO, CQO, GM, site heads, GMPKit command center
Focus Areas:
- Network-wide performance dashboard
- COPQ trends and financial impact
- Strategic initiative progress
- Cross-site benchmarking insights
Quarterly Strategy Reviews
Quarterly (Half-day)
Executive leadership, site heads, key stakeholders
Focus Areas:
- Strategy deployment effectiveness
- Goal achievement and gap analysis
- Resource reallocation decisions
- Next quarter priorities and targets
How We Design Governance Systems
We don't force a one-size-fits-all framework. We work with your existing structure and supplement only where gaps exist—ensuring governance routines fit your culture and capabilities.
Assess Existing Governance
We evaluate your current governance structure—meeting cadence, KPI visibility, escalation paths, and decision-making effectiveness. We identify what's working and what's broken.
Work with Your Structure
We adapt to your existing organizational model whenever possible. We don't force a one-size-fits-all framework—we tailor governance routines to your culture and capabilities.
Supplement When Needed
If your governance system is broken or missing, we implement our proven PDCA-structured LEAN governance framework—designed specifically for pharmaceutical manufacturing operations.
Enable Digital Visibility
We integrate BatchTrak™ to provide real-time performance dashboards that make governance reviews data-driven, not anecdotal. Leadership sees exactly where execution is breaking.
Our Philosophy:
Once we have our strategy translation and diagnostic checklist, we ensure that your existing governance model is sufficient to drive the needed changes. We work with your existing structure, but if it's broken or missing, we supplement it with our proven PDCA-structured LEAN governance system.
What Makes Our Approach Different
We're not traditional consultants who impose their governance framework regardless of fit. We bring fresh thinking grounded in 40+ years of pharmaceutical operations experience.
We Don't Force a Framework
Unlike consultants who impose their governance model regardless of fit, we work with your existing structure and only supplement where gaps exist.
Designed for Pharmaceutical Manufacturing
Our governance framework is purpose-built for GMP environments—balancing compliance requirements with operational efficiency and continuous improvement.
Sustained After We Leave
We design governance systems that your teams can sustain independently. By day 120, you'll have the routines, tools, and capabilities to maintain improvement without us.
Data-Driven, Not Anecdotal
We integrate BatchTrak™ to ensure governance reviews are grounded in real-time data—batch flow, deviation trends, COPQ impact—not gut feel or outdated reports.
Results You Can Expect
By day 120, you'll have governance routines that sustain improvement long after we leave—not just documentation, but actual operational discipline.
Sustained Improvement
Performance gains maintained 12+ months after engagement ends
Early Warning System
Problems identified and escalated before they become crises
Clear Accountability
Every metric has an owner, every problem has an escalation path
Inspection-Ready
Governance routines that demonstrate control and continuous improvement to regulators
Our Promise:
We design governance systems that your teams can sustain independently. We don't create dependency—we build capability. By day 120, you'll have the routines, tools, and discipline to maintain improvement without us.
Related Approaches
Governance systems ensure that strategy deployment and diagnostics translate into sustained results.
Ready to Build Governance That Sticks?
When your manufacturing network needs disciplined execution routines that sustain improvement, let's discuss how GMPKit can design governance systems tailored to your organization.