Assessment: Discovery First, Always
Quick Navigation: Overview • Challenges • Typical Engagement • Our Approach • Client Profile
Service Overview
Independent assessment reveals what’s actually blocking your operations before solutions are implemented. Most quality and compliance problems get misdiagnosed - companies pursue ISO certification when the real issue is validation evidence, or overhaul their QMS when the problem is specific and fixable. We provide objective evaluation of quality, validation, and compliance challenges, delivering clear analysis of root causes and prioritized action plans.
Common Challenges
Organizations struggle with quality and compliance issues where the symptoms are visible but root causes remain unclear, leading to expensive solutions that don’t address actual problems. Traditional consulting approaches push predetermined solutions rather than conducting systematic discovery. Here are specific situations requiring independent assessment:
SOP quality and operational disconnect where documented procedures don’t match how work actually gets done, creating compliance risk when auditors compare batch records to SOPs or when new personnel trained on procedures encounter contradictory operational reality.
Training records management failures where evidence is scattered across LMS, SharePoint, manual folders, and email confirmations, making it impossible to efficiently correlate training dates to SOP versions and documented work when auditors request evidence.
Validation strategy gaps where current CSV approaches don’t extend to AI components, digital tools, or modern software assurance frameworks, leaving organizations unable to qualify emerging technologies for GxP use.
Post-M&A quality system integration where control documents, validation frameworks, and quality processes remain separate months after acquisition, creating regulatory risk and operational inefficiency across the combined organization.
Review and approval bottlenecks where validation documents spend more time in review cycles than creation, not because of thoroughness but due to unclear criteria, wrong reviewers, or lack of executive enforcement when leaders sit on approvals for weeks.
Audit readiness gaps where simple inspector requests take hours to fulfill, triggering expanded audit scope as delays signal inadequate controls to regulatory agencies.
Change control over-validation where every system update triggers full revalidation regardless of risk level, keeping validated systems on outdated versions and creating unnecessary compliance burden.
Most quality and compliance failures occur because organizations implement solutions without understanding root causes, leading to expensive programs that don’t solve actual problems.
Recent Engagements
- Technology vendor assessment revealing SOP development process disconnected from operational SMEs, producing documentation that didn’t reflect actual workflows
- Biotech company training records analysis identifying systematic gaps in correlation between training completion, SOP version control, and documented work execution
- Medical device manufacturer validation strategy review exposing lack of frameworks for qualifying AI components under FDA CSA guidance
Typical Engagement
Duration: 2-4 weeks for comprehensive assessment, depending on scope and organizational complexity
Deliverables: Gap analysis report with verified issues and supporting evidence, action plan with prioritized tasks including severity, level of effort, and suggested ownership
Client involvement: Executive sponsor designation, key personnel interviews (1-2 hours each), documentation access, process observation where applicable
Engagement model: Fixed-price project for defined scope, with option for implementation support based on assessment findings
Our Assessment Approach
1. Initial Consultation (No Cost) We start with a consultation call to understand your situation - describe the problem as you see it, discuss potential causes, review constraints, and determine if assessment is the right next step.
2. Systematic Discovery We evaluate processes, systems, and documentation through interviews, document review, and operational observation to identify where actual practices diverge from documented procedures or regulatory requirements.
3. Root Cause Analysis We determine why problems exist rather than just cataloging symptoms, distinguishing between process gaps, resource constraints, organizational dysfunction, and technology limitations that require different solutions.
4. Gap Analysis Report We document verified issues with supporting evidence, compliance and operational risks, and regulatory or industry standard references where applicable, providing clear understanding of current state versus required state.
5. Prioritized Action Plan We deliver clear, concise tasks to address each gap, with severity level, level of effort, priority rating, and suggestions for who should execute each task, enabling informed decisions about sequencing and resource allocation.
6. Client Decision Framework The assessment and action plan are yours - you decide whether to execute internally, engage another firm, or bring us in for implementation if it’s in our scope.
Integration Points
Assessment connects with all implementation services - findings drive validation strategy development, ISO certification planning, system implementation requirements, or fractional leadership engagement scope depending on identified gaps and organizational priorities.
Change management considerations emerge from assessment when solutions require organizational behavior change rather than just process documentation, while training needs surface when competency gaps contribute to quality or compliance issues.
Client Profile
Organizations experiencing quality or compliance problems where symptoms are clear but root causes remain uncertain, or where previous solution attempts failed to resolve underlying issues. Particularly valuable for companies facing audit findings, considering major quality system investments, integrating acquisitions, or needing objective evaluation before committing resources to specific improvement programs.
Ready to start with an assessment? Schedule a Free Consultation to discuss your quality and compliance challenges.
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