Operational Diagnostics
Identify Where Strategy Breaks Down
We pinpoint constraints, execution gaps, and operational inefficiencies in weeks, not months—using a structured diagnostic framework that reveals exactly where your manufacturing network is failing.
The Diagnostic Challenge
When pharmaceutical manufacturing performance deteriorates, executives need rapid diagnostics to identify root causes and prioritize interventions. Traditional assessments take too long and deliver generic recommendations.
You Know Something's Wrong
Batch failures are climbing, deviations are piling up, and COPQ is eroding margins—but you can't pinpoint where the breakdown is happening.
Traditional Assessments Take Too Long
Most consulting firms spend 3-6 months studying your operations before recommending anything. You need answers in weeks, not months.
Data Without Insights
You have mountains of data but no clear picture of which constraints are killing your performance or where to focus improvement efforts.
The Three Whats Framework
Our diagnostic approach is structured around a proven philosophy that ensures data, insights, and actions are systematically aligned to drive meaningful outcomes.
The What
Capture the Facts
We establish a factual baseline of current performance by capturing key operational and quality data—batch disposition status, deviation patterns, excursion trends, and workflow bottlenecks.
Examples:
- Batch success rates and failure modes
- Deviation backlog size and age distribution
- Disposition pipeline throughput times
- Cross-functional handoff delays
So What
Analyze the Impact
We interpret the data to understand its significance—identifying risks, inefficiencies, and trends that affect compliance, production reliability, and operational effectiveness.
Examples:
- Root causes of batch failures
- Constraint analysis using Theory of Constraints
- COPQ impact quantification
- Regulatory risk exposure assessment
Now What
Design Solutions
We transform insights into actionable solutions—targeted interventions that optimize workflows, improve decision-making, and restore operational stability in 90-120 days.
Examples:
- Prioritized improvement roadmap
- Quick wins vs. strategic initiatives
- Resource allocation recommendations
- Governance system design
What We Diagnose
Our diagnostic checklist evaluates front-line operations management across six critical areas—ensuring alignment with GMP standards, regulatory requirements, and industry best practices.
Batch Disposition Performance
- Batch success rates and failure patterns
- Disposition pipeline throughput
- Hold time analysis and aging batches
- Release decision-making effectiveness
Deviation Management
- Backlog size, age, and growth trends
- Investigation cycle times
- Repeat deviation patterns
- CAPA effectiveness and closure rates
Excursion & OOS Management
- Excursion frequency and severity
- Out-of-specification investigation quality
- Trend analysis and early warning signals
- Process capability and control limits
Cross-Functional Workflows
- Handoff delays between Operations and Quality
- Decision-making authority and escalation paths
- Communication effectiveness
- Role clarity and accountability gaps
Front-Line Operations Management
- Supervisor effectiveness and span of control
- Real-time problem-solving capability
- Standard work adherence
- Training effectiveness and knowledge gaps
Governance & Performance Systems
- Performance review cadence and effectiveness
- KPI visibility and actionability
- Escalation mechanisms
- Continuous improvement culture
Quality System Agnostic:
Our diagnostic framework integrates with any existing quality management system—we adapt to your environment while ensuring a standardized approach to operational readiness, risk mitigation, and continuous improvement.
How We Execute Diagnostics
We complete diagnostics in 2-4 weeks, not 3-6 months. When your manufacturing network is in crisis, speed matters—but so does accuracy.
Rapid Data Collection
We deploy our diagnostic checklist across your manufacturing network, capturing operational and quality data through structured interviews, system reviews, and workflow observations.
Deliverable:
Factual baseline of current performance (The What)
Constraint Analysis
We analyze the data using LEAN principles and Theory of Constraints to identify where strategy execution is breaking—pinpointing bottlenecks, inefficiencies, and risk exposure.
Deliverable:
Impact assessment and root cause analysis (So What)
Solution Design
We design a prioritized improvement roadmap with quick wins and strategic initiatives—targeted interventions that address root causes, not just symptoms.
Deliverable:
Actionable execution plan (Now What)
Hands-On Implementation
We partner with your site teams to execute the plan—implementing governance systems, accelerating backlogs, and deploying BatchTrak™ for digital visibility.
Deliverable:
Measurable results in 90-120 days
What Makes Our Diagnostics Different
We're not traditional consultants who spend months studying your problems. We've lived pharmaceutical manufacturing operations—we know where to look and what questions to ask.
Quality System Agnostic
Our diagnostic framework integrates with any existing quality management system—we adapt to your environment, not the other way around.
Weeks, Not Months
We complete diagnostics in 2-4 weeks, not 3-6 months. When your network is in crisis, speed matters.
Execution-Focused
We don't just deliver a diagnostic report and leave. We stay to implement solutions and deliver measurable results.
Pharmaceutical Specialists
We've lived front-line pharmaceutical operations—we understand GMP requirements, regulatory expectations, and the realities of batch manufacturing.
Our Promise:
We don't just deliver a diagnostic report and leave. We partner with your site teams to execute the solutions—implementing governance systems, accelerating backlogs, and deploying BatchTrak™ for digital visibility. By day 120, you'll have measurable results, not just recommendations.
Related Approaches
Operational diagnostics reveal where to focus—our other key activities deliver the solutions.
Ready to Diagnose What's Breaking?
When your manufacturing network is failing and you need rapid diagnostics to identify root causes, let's discuss how GMPKit can pinpoint constraints and design solutions in weeks, not months.