Recent Podcast Appearance: Risk Revolution

I’m excited to share that I recently had the opportunity to appear on the Risk Revolution podcast, joining host Valerie Mulholland for what turned out to be a provocative and deeply engaging conversation about the future of pharmaceutical quality management.

The episode, titled “Quality Theatre to Quality Science – Jeremiah Genest’s Playbook,” aired on September 28, 2025, and dives into one of my core arguments: that quality systems should be designed to fail predictably so we can learn purposefully. This isn’t about celebrating failure—it’s about building systems intelligent enough to fail in ways that generate learning rather than hiding in the shadows until catastrophic breakdown occurs.

Why This Conversation Matters

Valerie and I spent over an hour exploring what I call “intelligent failure”—a concept that challenges the feel-good metrics that dominate our industry dashboards. You know the ones I’m talking about: those green lights celebrating zero deviations that make everyone feel accomplished while potentially masking the unknowns lurking beneath the surface. As I argued in the episode, these metrics can hide systemic problems rather than prove actual control.

This discussion connects directly to themes I’ve been developing here on Investigations of a Dog, particularly my thoughts on the effectiveness paradox and the dangerous comfort of “nothing bad happened” thinking. The podcast gave me a chance to explore how zemblanity—the patterned recurrence of unfortunate events that we should have anticipated—manifests in quality systems that prioritize the appearance of control over genuine understanding.

The Perfect Platform for These Ideas

Risk Revolution proved to be the ideal venue for this conversation. Valerie brings over 25 years of hands-on experience across biopharmaceutical, pharmaceutical, medical device, and blood transfusion industries, but what sets her apart is her unique combination of practical expertise and cutting-edge research.

The podcast’s monthly format allows for the kind of deep, nuanced discussions that advance risk management maturity rather than recycling conference presentations. When I wrote about Valerie’s writing on the GI Joe Bias, I noted how her emphasis on systematic interventions rather than individual awareness represents exactly the kind of sophisticated thinking our industry needs. This podcast appearance let us explore these concepts in real-time conversation.

What made the discussion particularly engaging was Valerie’s ability to challenge my thinking while building on it. Her research-backed insights into cognitive bias management created a perfect complement to my practical experience with system failures and investigation patterns. We explored how quality professionals—precisely because of our expertise—become vulnerable to specific blind spots that systematic design can address.

Looking Forward

This Risk Revolution appearance represents more than just a podcast interview—it’s part of a broader conversation about advancing pharmaceutical quality management beyond surface-level compliance toward genuine excellence. The episode includes references to my blog work, the Deming philosophy, and upcoming industry conferences where these ideas will continue to evolve.

If you’re interested in how quality systems can be designed for intelligent learning rather than elegant hiding, this conversation offers both provocative challenges and practical frameworks. Fair warning: you might never look at a green dashboard the same way again.

The episode is available now, and I’d love to hear your thoughts on how we might move from quality theatre toward quality science in your own organization.

Building Digital Trust: How Modern Infrastructure Transforms CxO-Sponsor Relationships Through Quality Agreements

The relationship between sponsors and contract organizations has evolved far beyond simple transactional exchanges. Digital infrastructure has become the cornerstone of trust, transparency, and operational excellence.

The trust equation is fundamentally changing due to the way our supply chains are being challenged.. Traditional quality agreements often functioned as static documents—comprehensive but disconnected from day-to-day operations. Today’s most successful partnerships are built on dynamic, digitally-enabled frameworks that provide real-time visibility into performance, compliance, and risk management.

Regulatory agencies are increasingly scrutinizing the effectiveness of sponsor oversight programs. The FDA’s emphasis on data integrity, combined with EMA’s evolving computerized systems requirements, means that sponsors can no longer rely on periodic audits and static documentation to demonstrate control over their outsourced activities.

Quality Agreements as Digital Trust Frameworks

The modern quality agreement must evolve from a compliance document to a digital trust framework. This transformation requires reimagining three fundamental components:

Dynamic Risk Assessment Integration

Traditional quality agreements categorize suppliers into static risk tiers (for example Category 1, 2, 2.5, or 3 based on material/service risk). Digital frameworks enable continuous risk profiling that adapts based on real-time performance data.

Integrate supplier performance metrics directly into your quality management system. When a Category 2 supplier’s on-time delivery drops below threshold or quality metrics deteriorate, the system should automatically trigger enhanced monitoring protocols without waiting for the next periodic review.

Automated Change Control Workflows

One of the most contentious areas in sponsor-CxO relationships involves change notifications and approvals. Digital infrastructure can transform this friction point into a competitive advantage.

The SMART approach to change control:

Standardized digital templates for change notifications
Machine-readable impact assessments
Automated routing based on change significance
Real-time status tracking for all stakeholders
Traceable decision logs with electronic signatures

Quality agreement language to include: “All change notifications shall be submitted through the designated digital platform within [X] business days of identification, with automated acknowledgment and preliminary impact assessment provided within [Y] hours.”

Transparent Performance Dashboards

The most innovative CxOs are moving beyond quarterly business reviews to continuous performance visibility. Quality agreements should build upon real-time access to key performance indicators (KPIs) that matter most to patient safety and product quality.

Examples of Essential KPIs for digital dashboards:

Batch disposition times and approval rates
Deviation investigation cycle times
CAPA effectiveness metrics
Environmental monitoring excursions and response times
Supplier change notification compliance rates

Communication Architecture for Transparency

Effective communication in pharmaceutical partnerships requires architectural thinking, not just protocol definition. The most successful CxO-sponsor relationships are built on what I call the “Three-Layer Communication Stack” which builds a rhythm of communication:

Layer 1: Operational Communication (Real-Time)

Purpose: Day-to-day coordination and issue resolution
Tools: Integrated messaging within quality management systems, automated alerts, mobile notifications
Quality agreement requirement: “Operational communications shall be conducted through validated, audit-trailed platforms with 24/7 availability and guaranteed delivery confirmation.”

Layer 2: Technical Communication (Scheduled)

Purpose: Performance reviews, trend analysis, continuous improvement
Tools: Shared analytics platforms, collaborative dashboards, video conferencing with screen sharing
Governance: Weekly operational reviews, monthly performance assessments, quarterly strategic alignments

Layer 3: Strategic Communication (Event-Driven)

Purpose: Relationship governance, escalation management, strategic planning
Stakeholders: Quality leadership, senior management, regulatory affairs
Framework: Joint steering committees, annual partnership reviews, regulatory alignment sessions

The Communication Plan Template

Every quality agreement should include a subsidiary Communication Plan that addresses:

Stakeholder Matrix: Who needs what information, when, and in what format
Escalation Protocols: Clear triggers for moving issues up the communication stack
Performance Metrics: How communication effectiveness will be measured and improved
Technology Requirements: Specified platforms, security requirements, and access controls
Contingency Procedures: Alternative communication methods for system failures or emergencies

Include communication effectiveness as a measurable element in your supplier scorecards. Track metrics like response time to quality notifications, accuracy of status reporting, and proactive problem identification.

Data Governance as a Competitive Differentiator

Data integrity is more than just ensuring ALCOA+—it’s about creating a competitive moat through superior data governance. The organizations that master data sharing, analysis, and decision-making will dominate the next decade of pharmaceutical manufacturing and development.

The Modern Data Governance Framework

Data Architecture Definition

Your quality agreement must specify not just what data will be shared, but how it will be structured, validated, and integrated:

Master data management: Consistent product codes, batch numbering, and material identifiers across all systems
Data quality standards: Validation rules, completeness requirements, and accuracy thresholds
Integration protocols: APIs, data formats, and synchronization frequencies

Access Control and Security

With increasing regulatory focus on cybersecurity, your data governance plan must address:

Role-based access controls: Granular permissions based on job function and business need
Data classification: Confidentiality levels and handling requirements
Audit logging: Comprehensive tracking of data access, modification, and sharing

Analytics and Intelligence

The real competitive advantage comes from turning shared data into actionable insights:

Predictive analytics: Early warning systems for quality trends and supply chain disruptions
Benchmark reporting: Anonymous industry comparisons to identify improvement opportunities
Root cause analysis: Automated correlation of events across multiple systems and suppliers

The Data Governance Subsidiary Agreement

Consider creating a separate Data Governance Agreement that complements your quality agreement with specific sections covering data sharing objectives, technical architecture, governance oversight, and compliance requirements.

Veeva Summit

Next week I’ll be discussing this topic at the Veeva Summit, where I will bring some organizational learnings on to embrace digital infrastructure as a trust-building mechanism will forge stronger partnerships, achieve superior quality outcomes, and ultimately deliver better patient experiences.

Risk Assessments as part of Design and Verification

Facility design and manufacturing processes are complex, multi-stage operations, fraught with difficulty. Ensuring the facility meets Good Manufacturing Practice (GMP) standards and other regulatory requirements is a major challenge. The complex regulations around biomanufacturing facilities require careful planning and documentation from the earliest design stages.

Which is why consensus standards like ASTM E2500 exist.

Central to these approaches are risk assessment, to which there are three primary components:

An understanding of the uncertainties in the design (which includes materials, processing, equipment, personnel, environment, detection systems, feedback control)
An identification of the hazards and failure mechanisms
An estimation of the risks associated with each hazard and failure

Folks often get tied up on what tool to use. Frankly, this is a phase approach. We start with a PHA for design, an FMEA for verification and a HACCP/Layers of Control Analysis for Acceptance. Throughout we use a bow-tie for communication.

Aspect	Bow-Tie	PHA (Preliminary Hazard Analysis)	FMEA (Failure Mode and Effects Analysis)	HACCP (Hazard Analysis and Critical Control Points)
Primary Focus	Visualizing risk pathways	Early hazard identification	Potential failure modes	Systematically identify, evaluate, and control hazards that could compromise product safety
Timing in Process	Any stage	Early development	Any stage, often design	Throughout production
Approach	Combines causes and consequences	Top-down	Bottom-up	Systematic prevention
Complexity	Moderate	Low to moderate	High	Moderate
Visual Representation	Central event with causes and consequences	Tabular format	Tabular format	Flow diagram with CCPs
Risk Quantification	Can include, not required	Basic risk estimation	Risk Priority Number (RPN)	Not typically quantified
Regulatory Alignment	Less common in pharma	Aligns with ISO 14971	Widely accepted in pharma	Less common in pharma
Critical Points	Identifies barriers	Does not specify	Identifies critical failure modes	Identifies Critical Control Points (CCPs)
Scope	Specific hazardous event	System-level hazards	Component or process-level failures	Process-specific hazards
Team Requirements	Cross-functional	Less detailed knowledge needed	Detailed system knowledge	Food safety expertise
Ongoing Management	Can be used for monitoring	Often updated periodically	Regularly updated	Continuous monitoring of CCPs
Output	Visual risk scenario	List of hazards and initial risk levels	Prioritized list of failure modes	HACCP plan with CCPs
Typical Use in Pharma	Risk communication	Early risk identification	Detailed risk analysis	Product Safety/Contamination Control

At BOSCON this year I’ll be talking about this fascinating detail, perhaps too much detail.

4th GxP Cloud Compliance Summit – September 5-7

I am looking forward to speaking at the GxP Cloud Compliance Summit in Boston in September on Implementing a Lifecycle Risk Management Approach to the Cloud. I’ll be discussing some of my favorite topics:

Best practices to harness a life cycle risk management approach to protect product quality and patient data
What does a living risk assessment look like when key parts of your IT infrastructure is maintained by cloud service providers
How does Q9 R1 impact functional and usage assessments around cloud applications

I am looking forward to meeting and discussing some of the critical questions in our heady embrace of the cloud.

Cloud based GxP systems have shifted in the last few years from “Something I guess we should figure out” to “Well guess we have it now” to “Well that is all I seem to have now.” And where 5 years ago it seemed we were obsessed about the fine details of Open vs Closed systems and what cloud-based applications are, we are now looking at much more mature questions around a risk based strategy that evaluates and ensures appropriate controls around Data Integrity, Privacy, and Security. Through a risk-based approach, we drive activities such as auditing, change control, qualification/validation, and oversight.

I am looking forward to having this discussion with my peers and sharing best practices and experiences. It is only though this type of event that we can grow as a professional.

I hope to see you there.

You, Yes You! Speak at a Conference

The process of writing and speaking is a core part of the Quality profession. Only through these activities can we truly contemplate and learn from our accomplishments to propel us forward to new heights.

There are some great speaking opportunities for folks around the Boston area coming up:

BOSCON is November 6 and 7th and is looking for speakers. I’m a huge fan of this regional convention and strongly recommend it. Submissions are due August 15th, 2023.

BOSCON 2023- Nov 6&7-Call for Speaker

The ASQ’s Quality Innovations Summit (formerly the Quality 4.0 Summit) is September 19–21 in Boston, MA with a theme of “Innovations and Future Trends for Excellence.” Submission deadline is June 9th, 2023, with more information here.

I’m quite happy to help coach potential new speakers, both in the development of your proposal and in your presentation.

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