Quality Systems as Living Organizations: A Framework for Adaptive Excellence

The allure of shiny new tools in quality management is undeniable. Like magpies drawn to glittering objects, professionals often collect methodologies and technologies without a cohesive strategy. This “magpie syndrome” creates fragmented systems—FMEA here, 5S there, Six Sigma sprinkled in—that resemble disjointed toolkits rather than coherent ecosystems. The result? Confusion, wasted resources, and quality systems that look robust on paper but crumble under scrutiny. The antidote lies in reimagining quality systems not as static machines but as living organizations that evolve, adapt, and thrive.

The Shift from Machine Logic to Organic Design

Traditional quality systems mirror 20th-century industrial thinking: rigid hierarchies, linear processes, and documents that gather dust. These systems treat organizations as predictable machines, relying on policies to command and procedures to control. Yet living systems—forests, coral reefs, cities—operate differently. They self-organize around shared purpose, adapt through feedback, and balance structure with spontaneity. Deming foresaw this shift. His System of Profound Knowledge—emphasizing psychology, variation, and systems thinking—aligns with principles of living systems: coherence without control, stability with flexibility.

At the heart of this transformation is the recognition that quality emerges not from compliance checklists but from the invisible architecture of relationships, values, and purpose. Consider how a forest ecosystem thrives: trees communicate through fungal networks, species coexist through symbiotic relationships, and resilience comes from diversity, not uniformity. Similarly, effective quality systems depend on interconnected elements working in harmony, guided by a shared “DNA” of purpose.

The Four Pillars of Living Quality Systems

  1. Purpose as Genetic Code
    Every living system has inherent telos—an aim that guides adaptation. For quality systems, this translates to policies that act as genetic non-negotiables. For pharmaceuticals and medical devices this is “patient safety above all.”. This “DNA” allowed teams to innovate while maintaining adherence to core requirements, much like genes express differently across environments without compromising core traits.
  2. Self-Organization Through Frameworks
    Complex systems achieve order through frameworks as guiding principles. Coherence emerges from shared intent. Deming’s PDSA cycles and emphasis on psychological safety create similar conditions for self-organization.
  3. Documentation as a Nervous System
    The enhanced document pyramid—policies, programs, procedures, work instructions, records—acts as an organizational nervous system. Adding a “program” level between policies and procedures bridges the gap between intent and action and can transform static documents into dynamic feedback loops.
  4. Maturity as Evolution
    Living systems evolve through natural selection. Maturity models serve as evolutionary markers:
    • Ad-hoc (Primordial): Tools collected like random mutations.
    • Managed (Organized): Basic processes stabilize.
    • Standardized (Complex): Methodologies cohere.
    • Predictable (Adaptive): Issues are anticipated.
    • Optimizing (Evolutionary): Improvement fuels innovation.

Cultivating Organizational Ecosystems: Eight Principles

Living quality systems thrive when guided by eight principles:

  • Balance: Serving patients, employees, and regulators equally.
  • Congruence: Aligning tools with culture.
  • Human-Centered: Designing for joy—automating drudgery, amplifying creativity.
  • Learning: Treating deviations as data, not failures.
  • Sustainability: Planning for decade-long impacts, not quarterly audits.
  • Elegance: Simplifying until it hurts, then relaxing slightly.
  • Coordination: Cross-pollinating across the organization
  • Convenience: Making compliance easier than non-compliance.

These principles operationalize Deming’s wisdom. Driving out fear (Point 8) fosters psychological safety, while breaking down barriers (Point 9) enables cross-functional symbiosis.

The Quality Professional’s New Role: Gardener, Not Auditor

Quality professionals must embrace a transformative shift in their roles. Instead of functioning as traditional enforcers or document controllers, we are now called to act as stewards of living systems. This evolution requires a mindset change from one of rigid oversight to one of nurturing growth and adaptability. The modern quality professional takes on new identities such as coach, data ecologist, and systems immunologist—roles that emphasize collaboration, learning, and resilience.

To thrive in this new capacity, practical steps must be taken. First, it is essential to prune toxic practices by eliminating fear-driven reporting mechanisms and redundant tools that stifle innovation and transparency. Quality professionals should focus on fostering trust and streamlining processes to create healthier organizational ecosystems. Next, they must plant feedback loops by embedding continuous learning into daily workflows. For instance, incorporating post-meeting retrospectives can help teams reflect on successes and challenges, ensuring ongoing improvement. Lastly, cross-pollination is key to cultivating diverse perspectives and skills. Rotating staff between quality assurance, operations, and research and development encourages knowledge sharing and breaks down silos, ultimately leading to more integrated and innovative solutions.

By adopting this gardener-like approach, quality professionals can nurture the growth of resilient systems that are better equipped to adapt to change and complexity. This shift not only enhances organizational performance but also fosters a culture of continuous improvement and collaboration.

Thriving, Not Just Surviving

Quality systems that mimic life—not machinery—turn crises into growth opportunities. As Deming noted, “Learning is not compulsory… neither is survival.” By embracing living system principles, we create environments where survival is the floor, and excellence is the emergent reward.

Start small: Audit one process using living system criteria. Replace one control mechanism with a self-organizing principle. Share learnings across your organizational “species.” The future of quality isn’t in thicker binders—it’s in cultivating systems that breathe, adapt, and evolve.

Communication Loops and Silos: A Barrier to Effective Decision Making in Complex Industries

In complex industries such as aviation and biotechnology, effective communication is crucial for ensuring safety, quality, and efficiency. However, the presence of communication loops and silos can significantly hinder these efforts. The concept of the “Tower of Babel” problem, as explored in the aviation sector by Follet, Lasa, and Mieusset in HS36, highlights how different professional groups develop their own languages and operate within isolated loops, leading to misunderstandings and disconnections. This article has really got me thinking about similar issues in my own industry.

The Tower of Babel Problem: A Thought-Provoking Perspective

The HS36 article provides a thought-provoking perspective on the “Tower of Babel” problem, where each aviation professional feels in control of their work but operates within their own loop. This phenomenon is reminiscent of the biblical story where a common language becomes fragmented, causing confusion and separation among people. In modern industries, this translates into different groups using their own jargon and working in isolation, making it difficult for them to understand each other’s perspectives and challenges.

For instance, in aviation, air traffic controllers (ATCOs), pilots, and managers each have their own “loop,” believing they are in control of their work. However, when these loops are disconnected, it can lead to miscommunication, especially when each group uses different terminology and operates under different assumptions about how work should be done (work-as-prescribed vs. work-as-done). This issue is equally pertinent in the biotech industry, where scientists, quality assurance teams, and regulatory affairs specialists often work in silos, which can impede the development and approval of new products.

Tower of Babel by Joos de Momper, Old Masters Museum

Impact on Decision Making

Decision making in biotech is heavily influenced by Good Practice (GxP) guidelines, which emphasize quality, safety, and compliance – and I often find that the aviation industry, as a fellow highly regulated industry, is a great place to draw perspective.

When communication loops are disconnected, decisions may not fully consider all relevant perspectives. For example, in GMP (Good Manufacturing Practice) environments, quality control teams might focus on compliance with regulatory standards, while research and development teams prioritize innovation and efficiency. If these groups do not effectively communicate, decisions might overlook critical aspects, such as the practicality of implementing new manufacturing processes or the impact on product quality.

Furthermore, ICH Q9(R1) guideline emphasizes the importance of reducing subjectivity in Quality Risk Management (QRM) processes. Subjectivity can arise from personal opinions, biases, or inconsistent interpretations of risks by stakeholders, impacting every stage of QRM. To combat this, organizations must adopt structured approaches that prioritize scientific knowledge and data-driven decision-making. Effective knowledge management is crucial in this context, as it involves systematically capturing, organizing, and applying internal and external knowledge to inform QRM activities.

Academic Research on Communication Loops

Research in organizational behavior and communication highlights the importance of bridging these silos. Studies have shown that informal interactions and social events can significantly improve relationships and understanding among different professional groups (Katz & Fodor, 1963). In the biotech industry, fostering a culture of open communication can help ensure that GxP decisions are well-rounded and effective.

Moreover, the concept of “work-as-done” versus “work-as-prescribed” is relevant in biotech as well. Operators may adapt procedures to fit practical realities, which can lead to discrepancies between intended and actual practices. This gap can be bridged by encouraging feedback and continuous improvement processes, ensuring that decisions reflect both regulatory compliance and operational feasibility.

Case Studies and Examples

  1. Aviation Example: The HS36 article provides a compelling example of how disconnected loops can hinder effective decision making in aviation. For instance, when a standardized phraseology was introduced, frontline operators felt that this change did not account for their operational needs, leading to resistance and potential safety issues. This illustrates how disconnected loops can hinder effective decision making.
  2. Product Development: In the development of a new biopharmaceutical, different teams might have varying priorities. If the quality assurance team focuses solely on regulatory compliance without fully understanding the manufacturing challenges faced by production teams, this could lead to delays or quality issues. By fostering cross-functional communication, these teams can align their efforts to ensure both compliance and operational efficiency.
  3. ICH Q9(R1) Example: The revised ICH Q9(R1) guideline emphasizes the need to manage and minimize subjectivity in QRM. For instance, in assessing the risk of a new manufacturing process, a structured approach using historical data and scientific evidence can help reduce subjective biases. This ensures that decisions are based on comprehensive data rather than personal opinions.
  4. Technology Deployment: . A recent FDA Warning Letter to Sanofi highlighted the importance of timely technological upgrades to equipment and facility infrastructure. This emphasizes that staying current with technological advancements is essential for maintaining regulatory compliance and ensuring product quality. However the individual loops of decision making amongst the development teams, operations and quality can lead to major mis-steps.

Strategies for Improvement

To overcome the challenges posed by communication loops and silos, organizations can implement several strategies:

  • Promote Cross-Functional Training: Encourage professionals to explore other roles and challenges within their organization. This can help build empathy and understanding across different departments.
  • Foster Informal Interactions: Organize social events and informal meetings where professionals from different backgrounds can share experiences and perspectives. This can help bridge gaps between silos and improve overall communication.
  • Define Core Knowledge: Establish a minimum level of core knowledge that all stakeholders should possess. This can help ensure that everyone has a basic understanding of each other’s roles and challenges.
  • Implement Feedback Loops: Encourage continuous feedback and improvement processes. This allows organizations to adapt procedures to better reflect both regulatory requirements and operational realities.
  • Leverage Knowledge Management: Implement robust knowledge management systems to reduce subjectivity in decision-making processes. This involves capturing, organizing, and applying internal and external knowledge to inform QRM activities.

Combating Subjectivity in Decision Making

In addition to bridging communication loops, reducing subjectivity in decision making is crucial for ensuring quality and safety. The revised ICH Q9(R1) guideline provides several strategies for this:

  • Structured Approaches: Use structured risk assessment tools and methodologies to minimize personal biases and ensure that decisions are based on scientific evidence.
  • Data-Driven Decision Making: Prioritize data-driven decision making by leveraging historical data and real-time information to assess risks and opportunities.
  • Cognitive Bias Awareness: Train stakeholders to recognize and mitigate cognitive biases that can influence risk assessments and decision-making processes.

Conclusion

In complex industries effective communication is essential for ensuring safety, quality, and efficiency. The presence of communication loops and silos can lead to misunderstandings and poor decision making. By promoting cross-functional understanding, fostering informal interactions, and implementing feedback mechanisms, organizations can bridge these gaps and improve overall performance. Additionally, reducing subjectivity in decision making through structured approaches and data-driven decision making is critical for ensuring compliance with GxP guidelines and maintaining product quality. As industries continue to evolve, addressing these communication challenges will be crucial for achieving success in an increasingly interconnected world.


References:

  • Follet, S., Lasa, S., & Mieusset, L. (n.d.). The Tower of Babel Problem in Aviation. In HindSight Magazine, HS36. Retrieved from https://skybrary.aero/sites/default/files/bookshelf/hs36/HS36-Full-Magazine-Hi-Res-Screen-v3.pdf
  • Katz, D., & Fodor, J. (1963). The Structure of a Semantic Theory. Language, 39(2), 170–210.
  • Dekker, S. W. A. (2014). The Field Guide to Understanding Human Error. Ashgate Publishing.
  • Shorrock, S. (2023). Editorial. Who are we to judge? From work-as-done to work-as-judged. HindSight, 35, Just Culture…Revisited. Brussels: EUROCONTROL.

Deep Rules

In his column “What You Still Can’t Say at Work” Jim Detert explores the concept of “deep rules” in organizations and their impact on workplace communication and culture. He convincingly argues that despite efforts to improve workplace communication and psychological safety, there are still unwritten “deep rules” that prevent employees from expressing certain thoughts and concerns, particularly those that challenge existing power structures or leadership practices.

To his very good list, I’d add a few around quality:

  • “Our leaders talk about quality but don’t actually prioritize it when making key decisions.”
  • “Employees aren’t truly empowered to make quality-related decisions, despite what our policy states.”
  • “We have processes in place mainly to pass audits, not because they actually improve quality.”
  • “Quality data is often manipulated or selectively presented to paint a more positive picture.”
  • “We make decisions based on politics or personal preferences rather than quality data and analysis.”

Remote Informal Communication

Additionally, organizations should promote informal communication as a vital aspect of team functioning, which could help reduce the pressure to constantly appear busy

Vanessa Begemann, Lisa Handke, Nale Lehmann-Willenbrock, Enabling and constraining factors of remote informal communication: a socio-technical systems perspective, Journal of Computer-Mediated Communication, Volume 29, Issue 5, September 2024, zmae008, https://doi.org/10.1093/jcmc/zmae008

Great little paper on informal communications in the remote workplace. The focus on the technology needing to be focused on (1) accessibility, (2) usability, (3) visibility, (4) selectivity, and (5) synchronicity is something that cannot be iterated enough.

I think one solution to a lot of what this article covers is a good, well defined, team charter.

Conducive Culture

Another building block to Quality Culture is conducive culture, which is an environment that promotes employee productivity, satisfaction, and well-being. There is a huge overlap between the concepts of a Just and Conducive Culture.

  1. Physical Comfort and Resources: Ensuring employees have a comfortable physical environment and the necessary resources to perform their tasks effectively.
  2. Open Communication: Encouraging transparent and open communication between employees and management helps build trust and fosters a sense of teamwork.
  3. Recognition and Reward: Regularly acknowledging and rewarding individual contributions can maintain high levels of employee motivation and engagement.
  4. Diversity, Equity, and Inclusion (DEI): Promoting a culture that values diversity, equity, and inclusion can lead to a more respectful and collaborative workplace, enhancing employee morale and productivity.
  5. Work-Life Balance: Supporting employees in achieving a healthy work-life balance through flexible working hours and telecommuting opportunities can increase their engagement and motivation.
  6. Positive Organizational Values: Establishing and operationalizing core values that align with collaboration, learning, and adapting (CLA) can create a supportive and innovative work environment.
  7. Feedback and Development: Regular, constructive feedback and opportunities for professional growth help employees feel valued and supported in their roles.
  8. Team Culture: Promoting teamwork and collective responsibility for outcomes can enhance the organization’s overall performance and success.

A conducive culture fosters innovation, collaboration, and inclusivity, all vital elements of a quality culture.