Diagnostic Frameworks
Identify the Gaps That Cause Strategy to Fail
Our diagnostic frameworks provide situational evaluation across leadership, compliance, operations, quality, and risk management—pinpointing where pharmaceutical manufacturing strategy breaks down and why.
What We Evaluate
Our diagnostic frameworks span 10 critical areas of pharmaceutical manufacturing operations. Evaluation is situational—we focus on the areas most relevant to your operational challenges and strategic priorities.
Leadership Culture
Evaluate leadership effectiveness, decision-making authority, accountability structures, and the cultural drivers that enable or prevent operational excellence.
Focus Areas:
- Executive alignment and communication
- Front-line supervisor effectiveness
- Decision-making speed and authority
- Continuous improvement culture
Regulatory Compliance
Assess GMP compliance, inspection readiness, regulatory risk exposure, and the effectiveness of quality systems in maintaining control.
Focus Areas:
- GMP adherence and control systems
- Inspection readiness and findings history
- CAPA effectiveness and closure rates
- Regulatory intelligence and change control
Documentation & Record Handling
Evaluate batch record quality, documentation practices, data integrity, and the efficiency of record review and approval processes.
Focus Areas:
- Batch record completeness and accuracy
- Electronic vs. paper system effectiveness
- Review cycle times and bottlenecks
- Data integrity and audit trail controls
Operations & Quality Synergy
Diagnose how effectively Operations and Quality teams collaborate—identifying handoff delays, communication gaps, and conflicting priorities.
Focus Areas:
- Cross-functional workflow effectiveness
- Handoff delays and escalation paths
- Role clarity and accountability
- Shared performance metrics
Data-Driven Operations
Assess the use of data for decision-making, KPI visibility, trend analysis, and the effectiveness of performance management systems.
Focus Areas:
- KPI definition and visibility
- Real-time performance monitoring
- Trend analysis and predictive capabilities
- Data accessibility and reporting tools
Process Validation & CPV
Evaluate process validation status, continuous process verification programs, and the ability to demonstrate process control.
Focus Areas:
- Validation lifecycle management
- CPV program effectiveness
- Process capability and control limits
- Change control impact assessment
Training & Personnel
Assess training effectiveness, competency verification, knowledge retention, and the ability to maintain qualified personnel.
Focus Areas:
- Training program design and delivery
- Competency assessment methods
- Knowledge gap identification
- Succession planning and retention
Exception Handling
Diagnose deviation management, investigation quality, root cause analysis effectiveness, and the ability to prevent recurrence.
Focus Areas:
- Deviation backlog and aging
- Investigation cycle times and quality
- Root cause analysis depth
- Preventive action effectiveness
Safety & Risk Management
Evaluate safety culture, risk assessment processes, hazard identification, and the integration of risk management into operations.
Focus Areas:
- Safety incident trends and response
- Risk assessment methodology
- Hazard identification and mitigation
- Risk-based decision making
Scheduling & Capacity
Assess production scheduling effectiveness, capacity utilization, constraint management, and the ability to meet demand predictably.
Focus Areas:
- Schedule adherence and reliability
- Capacity constraint identification
- Batch sequencing optimization
- Demand forecasting accuracy
How We Use Diagnostic Frameworks
Our frameworks are designed to identify the gaps that cause strategy to fail—not just document what's broken, but understand why and design solutions that work.
Situational Evaluation
Our diagnostic frameworks are not one-size-fits-all. We tailor the evaluation to your specific situation—focusing on the areas most critical to your operational challenges and strategic priorities.
Designed to Identify Strategy Failures
These frameworks are purpose-built to identify the gaps that cause strategy to fail—leadership misalignment, execution bottlenecks, accountability gaps, and cultural barriers to improvement.
Grounded in The Three Whats
Every diagnostic follows our proven philosophy: The What (capture facts), So What (analyze impact), Now What (design solutions)—ensuring insights translate into actionable improvements.
Quality System Agnostic
Our frameworks integrate with any existing quality management system—we adapt to your environment while ensuring a standardized approach to operational readiness and risk mitigation.
Situational Evaluation:
We don't evaluate all 10 areas in every engagement. We tailor the diagnostic to your specific situation—focusing on the areas most critical to restoring operational stability and executing your strategic priorities.
From Diagnosis to Results
We deploy diagnostic frameworks as part of our 90-120 day operational recovery engagement—not as standalone assessments that deliver reports and recommendations.
Rapid Assessment
We deploy diagnostic frameworks in the first 2-4 weeks of engagement to establish a factual baseline of current performance and identify where strategy execution is breaking.
Deliverable:
Diagnostic report with prioritized findings
Gap Analysis
We analyze diagnostic findings using LEAN principles and Theory of Constraints to pinpoint root causes, bottlenecks, and the highest-impact improvement opportunities.
Deliverable:
Root cause analysis and constraint identification
Solution Design
We translate diagnostic insights into a prioritized improvement roadmap—quick wins and strategic initiatives that address root causes, not just symptoms.
Deliverable:
90-120 day execution plan
Progress Tracking
We use diagnostic frameworks throughout the engagement to measure progress, validate improvements, and ensure strategy execution is on track.
Deliverable:
Measurable results and sustained improvement
What Makes Our Frameworks Different
We're not traditional consultants who deliver diagnostic reports and leave. We use these frameworks to design and execute solutions that restore operational stability.
Pharmaceutical Manufacturing Specialists
Our frameworks are designed by practitioners who've lived pharmaceutical operations—not generic consultants adapting frameworks from other industries.
Execution-Focused
We don't just deliver diagnostic reports. We use these frameworks to design and execute solutions that restore operational stability in 90-120 days.
Proven Across CDMOs and Innovators
These frameworks have been validated across mid-size CDMOs, large-scale biopharma sites, cell therapy operations, and gene therapy facilities.
Our Promise:
We don't just identify gaps—we partner with your site teams to close them. By day 120, you'll have measurable results: reduced COPQ, predictable batch flow, and inspection-ready performance.
Related Tools & Resources
Our diagnostic frameworks work alongside other key resources in the GMPKit toolkit.
Ready to Diagnose What's Breaking?
When your manufacturing network is failing and you need rapid diagnostics to identify where strategy is breaking down, let's discuss how GMPKit's diagnostic frameworks can pinpoint root causes in weeks, not months.