Tag: quality bookshelf

A Guide to Essential Safety Thinkers: Minds That Have Transformed Quality Through System Understanding

Safety science has evolved from a narrow focus on preventing individual errors to a sophisticated understanding of how complex socio-technical systems create both failure and resilience. The intellectual influences explored in this guide represent a paradigm shift from traditional “blame and fix” approaches to nuanced frameworks that recognize safety and quality as emergent properties of system design, organizational culture, and human adaptation.

These thinkers have fundamentally changed how quality professionals understand failure, risk, and the role of human expertise in creating reliable operations. Their work provides the theoretical foundation for moving beyond compliance-driven quality management toward learning-oriented, resilience-based approaches that acknowledge the inherent complexity of modern organizational systems.

System Failure and Accident Causation

Sidney Dekker

The architect of Safety Differently and New View thinking

Sidney Dekker has fundamentally transformed how we understand human error and system failure. His work challenges the traditional focus on individual blame, instead viewing errors as symptoms of deeper system issues. Dekker’s concept of “drift into failure” explains how systems gradually migrate toward unsafe conditions through seemingly rational local adaptations. His framework provides quality professionals with tools for understanding how organizational pressures and system design create the conditions for both success and failure.

James Reason

The Swiss Cheese model creator and error management pioneer

James Reason’s work provides the foundational framework for understanding how organizational failures create the conditions for accidents. His Swiss Cheese model demonstrates how multiple defensive layers must align for accidents to occur, shifting focus from individual error to organizational defenses. Reason’s 12 principles of error management offer practical guidance for building systems that can contain and learn from human fallibility.

Charles Perrow

The normal accidents theorist

Charles Perrow revolutionized safety thinking with his theory of “normal accidents” – the idea that in complex, tightly-coupled systems, catastrophic failures are inevitable rather than preventable. His work demonstrates why traditional engineering approaches to safety often fail in complex systems and why some technologies may be inherently too dangerous to operate safely. For quality professionals, Perrow’s insights are crucial for understanding when system redesign, rather than procedural improvements, becomes necessary.

Resilience Engineering and Adaptive Capacity

Erik Hollnagel

The resilience engineering pioneer and ETTO principle creator

Erik Hollnagel’s resilience engineering framework fundamentally shifts safety thinking from preventing things from going wrong (Safety-I) to understanding how things go right (Safety-II). His four cornerstones of resilience – the ability to respond, monitor, learn, and anticipate – provide quality professionals with a proactive framework for building adaptive capacity. The ETTO (Efficiency-Thoroughness Trade-Off) principle explains why organizations must balance competing demands and why perfect safety procedures are often impractical.

David Woods

The cognitive systems engineering founder

David Woods co-founded both cognitive systems engineering and resilience engineering, fundamentally changing how we understand human-system interaction. His concept of “graceful extensibility” explains how systems must be designed to adapt beyond their original parameters. Woods’ work on joint cognitive systems provides frameworks for understanding how human expertise and technological systems create integrated performance capabilities.

Systems Theory and Complexity

Nancy Leveson

The STAMP framework architect

Nancy Leveson’s Systems-Theoretic Accident Model and Processes (STAMP) provides a approach to understanding accidents in complex systems. Unlike traditional event-chain models, STAMP views accidents as control problems rather than failure problems. Her work is essential for quality professionals dealing with software-intensive systems and complex organizational interfaces where traditional hazard analysis methods prove inadequate.

Human and Organizational Performance

Todd Conklin

The Human and Organizational Performance (HOP) advocate

Todd Conklin’s five principles of Human and Organizational Performance represent a contemporary synthesis of decades of safety science research. His approach emphasizes that people make mistakes, blame fixes nothing, learning is vital, context drives behavior, and how we respond to failure shapes future performance. Conklin’s work provides quality professionals with practical frameworks for implementing research-based safety approaches in real organizational settings.

Organizational Learning and Safety Culture

Andrew Hopkins

The organizational accident analyst

Andrew Hopkins’ detailed analyses of major industrial disasters provide unparalleled insights into how organizational factors create the conditions for catastrophic failure. His work on the BP Texas City refinery disaster, Longford gas plant explosion, and other major accidents demonstrates how regulatory systems, organizational structure, and safety culture interact to create or prevent disasters. Hopkins’ narrative approach makes complex organizational dynamics accessible to quality professionals.

  • Safety, Culture and Risk: The Organisational Causes of Disasters (2005) – Essential framework for understanding how organizational culture shapes safety outcomes.

Carl Macrae

The healthcare resilience researcher

Carl Macrae’s work bridges safety science and healthcare quality, demonstrating how resilience engineering principles apply to complex care environments. His research on incident reporting, organizational learning, and regulatory systems provides quality professionals with frameworks for building adaptive capacity in highly regulated environments. Macrae’s work is particularly valuable for understanding how to balance compliance requirements with learning-oriented approaches.

  • Close Calls: Managing Risk and Resilience in Airline Flight Safety (2014) – Comprehensive analysis of how aviation creates reliability through systematic learning from near-misses.
  • Learning from Failure: Building Safer Healthcare through Reporting and Analysis (2016) – Essential guide to building effective organizational learning systems in regulated environments.

Philosophical Foundations of Risk and Speed

Paul Virilio

The dromology and accident philosopher

Paul Virilio’s concept of dromology – the study of speed and its effects – provides profound insights into how technological acceleration creates new forms of risk. His insight that “when you invent the ship, you also invent the shipwreck” explains how every technology simultaneously creates its potential for failure. For quality professionals in rapidly evolving technological environments, Virilio’s work explains how speed itself becomes a source of systemic risk that traditional quality approaches may be inadequate to address.

  • Essential Books: Speed and Politics (1986) – The foundational text on how technological acceleration reshapes power relationships and risk patterns.
  • The Information Bomb (2000) – Essential reading on how information technology acceleration creates new forms of systemic vulnerability.

This guide represents a synthesis of influences that have fundamentally transformed safety thinking from individual-focused error prevention to system-based resilience building. Each recommended book offers unique insights that, when combined, provide a comprehensive foundation for quality leadership that acknowledges the complex, adaptive nature of modern organizational systems. These thinkers challenge us to move beyond traditional quality management toward approaches that embrace complexity, foster learning, and build adaptive capacity in an uncertain world.

Let me know of others you recommend!

A Guide to Essential Thinkers and Their Works

A curated exploration of the minds that have shaped my approach to organizational excellence, systems thinking, and quality culture

Quality management has evolved far beyond its industrial roots to become a sophisticated discipline that draws from psychology, systems theory, organizational behavior, and strategic management. The intellectual influences that shape how we think about quality today represent a rich tapestry of thinkers who have fundamentally changed how organizations approach excellence, learning, and continuous improvement.

This guide explores the key intellectual influences that inform my quality thinking, organized around the foundational concepts they’ve contributed. For each thinker, I’ve selected two essential books that capture their most important contributions to quality practice.

I want to caution that this list is not meant to be complete. It really explores some of the books I’ve been using again and again as I explore many of the concepts on this blog. Please share your foundational books in the comments!

And to make life easier, I provided links to the books.

https://bookshop.org/lists/quality-thinkers

Psychological Safety and Organizational Learning

Amy Edmondson

The pioneer of psychological safety research

Amy Edmondson’s work has revolutionized our understanding of how teams learn, innovate, and perform at their highest levels. Her research demonstrates that psychological safety—the belief that one can speak up without risk of punishment or humiliation—is the foundation of high-performing organizations.

Essential Books:

  1. The Fearless Organization: Creating Psychological Safety in the Workplace for Learning, Innovation, and Growth (2018) – The definitive guide to understanding and building psychological safety in organizations.
  2. The 4 Stages of Psychological Safety (HBR Emotional Intelligence Series) (2024) – A practical handbook featuring Edmondson’s latest insights alongside other leading voices in the field.

Timothy Clark

The architect of staged psychological safety development

Timothy Clark has extended Edmondson’s foundational work by creating a practical framework for how psychological safety develops in teams. His four-stage model provides leaders with a clear pathway for building psychologically safe environments.

Essential Books:

  1. The 4 Stages of Psychological Safety: Defining the Path to Inclusion and Innovation (2020) – Clark’s comprehensive framework for understanding how teams progress through inclusion safety, learner safety, contributor safety, and challenger safety.
  2. The 4 Stages of Psychological Safety™ Behavioral Guide (2025) – A practical companion with over 120 specific behaviors for implementing psychological safety in daily work.

Decision-Making and Risk Management

Gerd Gigerenzer

The champion of bounded rationality and intuitive decision-making

Gigerenzer’s work challenges the notion that rational decision-making requires complex analysis. His research demonstrates that simple heuristics often outperform sophisticated analytical models, particularly in uncertain environments—a key insight for quality professionals facing complex organizational challenges.

Essential Books:

  1. Risk Savvy: How to Make Good Decisions (2014) – A practical guide to understanding risk and making better decisions in uncertain environments.
  2. Gut Feelings: The Intelligence of the Unconscious (2007) – Explores how intuitive decision-making can be superior to analytical approaches in many situations.

Change Management and Organizational Transformation

John Kotter

The authority on leading organizational change

Kotter’s systematic approach to change management has become the standard framework for organizational transformation. His eight-step process provides quality leaders with a structured approach to implementing quality initiatives and cultural transformation.

Essential Books:

  1. Leading Change (2012) – The classic text on organizational change management featuring Kotter’s legendary eight-step process.
  2. Our Iceberg Is Melting: Changing and Succeeding Under Any Conditions (2006) – A business fable that makes change management principles accessible and memorable.

Systems Thinking and Organizational Design

Donella Meadows

The systems thinking pioneer

Meadows’ work on systems thinking provides the intellectual foundation for understanding organizations as complex, interconnected systems. Her insights into leverage points and system dynamics are essential for quality professionals seeking to create sustainable organizational change.

Essential Books:

  1. Thinking in Systems (2008) – The essential introduction to systems thinking, with practical examples and clear explanations of complex concepts.

Peter Senge

The learning organization architect

Senge’s concept of the learning organization has fundamentally shaped how we think about organizational development and continuous improvement. His five disciplines provide a framework for building organizations capable of adaptation and growth.

Essential Books:

  1. The Fifth Discipline: The Art & Practice of the Learning Organization (2006) – The foundational text on learning organizations and the five disciplines of systems thinking.
  2. The Fifth Discipline Fieldbook: Strategies and Tools for Building a Learning Organization (1994) – A practical companion with tools and techniques for implementing learning organization principles.

Edgar Schein

The organizational culture architect

Schein’s three-layer model of organizational culture (artifacts, espoused values, and basic assumptions) is fundamental to your approach to quality culture assessment and development. Schein’s work provides the structural foundation for understanding how culture actually operates in organizations.

Essential Books:

  1. Organizational Culture and Leadership (5th Edition, 2016) – The definitive text on understanding and changing organizational culture, featuring the three-level model that shapes your quality culture work.
  2. Humble Inquiry: The Gentle Art of Asking Instead of Telling (2013) – Essential insights into leadership communication and building psychological safety through questioning rather than commanding.

Quality Management and Continuous Improvement

W. Edwards Deming

The quality revolution catalyst

Deming’s work forms the philosophical foundation of modern quality management. His System of Profound Knowledge provides a comprehensive framework for understanding how to transform organizations through quality principles.

Essential Books:

  1. Out of the Crisis (1982) – Deming’s classic work introducing the 14 Points for Management and the foundations of quality transformation.
  2. The New Economics for Industry, Government, Education (2000) – Deming’s mature thinking on the System of Profound Knowledge and its application across sectors.

Worker Empowerment and Democratic Management

Mary Parker Follett

The prophet of participatory management

Follett’s early 20th-century work on “power-with” rather than “power-over” anticipated modern approaches to worker empowerment and participatory management. Her insights remain remarkably relevant for building quality cultures based on worker engagement.

Essential Books:

  1. Mary Parker Follett: Prophet of Management (1994) – A collection of Follett’s essential writings with commentary by leading management thinkers.
  2. The New State: Group Organization the Solution of Popular Government (1918) – Follett’s foundational work on democratic organization and group dynamics.

Data Communication, Storytelling and Visual Thinking

Nancy Duarte

The data storytelling pioneer

Duarte’s work bridges the gap between data analysis and compelling communication. Her frameworks help quality professionals transform complex data into persuasive narratives that drive action.

Essential Books:

  1. DataStory: Explain Data and Inspire Action Through Story (2019) – The definitive guide to transforming data into compelling narratives that inspire action.
  2. Slide:ology: The Art and Science of Creating Great Presentations (2008) – Essential techniques for visual communication and presentation design.

Dave Gray

The visual thinking and organizational innovation pioneer

Gray’s work bridges abstract organizational concepts and actionable solutions through visual frameworks, collaborative innovation, and belief transformation. His methodologies help quality professionals make complex problems visible, engage teams in creative problem-solving, and transform the beliefs that undermine quality culture.

Essential Books:

  1. Gamestorming: A Playbook for Innovators, Rulebreakers, and Changemakers (2010) – Co-authored with Sunni Brown and James Macanufo, this foundational text provides over 80 structured activities for transforming how teams collaborate, innovate, and solve problems. Essential for quality professionals seeking to make quality improvement more engaging and creative. Now in a 2nd edition!
  2. Liminal Thinking: Create the Change You Want by Changing the Way You Think (2016) – Gray’s most profound work on organizational transformation, offering nine practical approaches for transforming the beliefs that shape organizational reality.

Strategic Planning and Policy Deployment

Hoshin Kanri Methodology

The Japanese approach to strategic alignment

While not attributed to a single author, Hoshin Kanri represents a sophisticated approach to strategic planning that ensures organizational alignment from top to bottom. The X-Matrix and catch-ball processes provide powerful tools for quality planning.

Essential Books:

  1. Implementing Hoshin Kanri: How to Manage Strategy Through Policy Deployment and Continuous Improvement (2021) – A comprehensive guide to implementing Hoshin Kanri based on real-world experience with 14 companies.
  2. Hoshin Kanri: Policy Deployment for Successful TQM (1991) – The classic introduction to Hoshin planning principles and practice.

Lean Manufacturing and Process Excellence

Taiichi Ohno and Shigeo Shingo

The Toyota Production System architects

These two pioneers created the Toyota Production System, which became the foundation for lean manufacturing and continuous improvement methodologies worldwide.

Essential Books:

  1. Toyota Production System: Beyond Large-Scale Production by Taiichi Ohno (1988) – The creator of TPS explains the system’s foundations and philosophy.
  2. Fundamental Principles of Lean Manufacturing by Shigeo Shingo (2021) – Recently translated classic providing deep insights into process improvement thinking.

Strategic Decision-Making and Agility

John Boyd

The OODA Loop creator

Boyd’s work on rapid decision-making cycles has profound implications for organizational agility and continuous improvement. The OODA Loop provides a framework for staying ahead of change and competition.

Essential Books:

  1. Science, Strategy and War: The Strategic Theory of John Boyd by Frans Osinga (2007) – The most comprehensive analysis of Boyd’s strategic thinking and its applications.
  2. Certain to Win: The Strategy of John Boyd, Applied to Business by Chet Richards (2004) – Practical application of Boyd’s concepts to business strategy.

Dave Snowden

The complexity theory pioneer and creator of the Cynefin framework

Snowden’s work revolutionizes decision-making by providing practical frameworks for navigating uncertainty and complexity. The Cynefin framework helps quality professionals understand what type of situation they face and choose appropriate responses, distinguishing between simple problems that need best practices and complex challenges requiring experimentation.

Essential Books:

  1. Cynefin – Weaving Sense-Making into the Fabric of Our World (2020) – The comprehensive guide to the Cynefin framework and its applications across healthcare, strategy, organizational behavior, and crisis management. Essential for quality professionals seeking to match their response to the nature of their challenges.
  2. A Leader’s Framework for Decision Making (2007 Harvard Business Review) – Co-authored with Mary Boone, this article provides the essential introduction to complexity-based decision-making. Critical reading for understanding when traditional quality approaches work and when they fail.

This guide represents a synthesis of influences that shape my quality thinking. Each recommended book offers unique insights that, when combined, provide a comprehensive foundation for quality leadership in the 21st century.

Spy Novels and Me as a Quality Professional

One of the best interview questions anyone ever asked me was about my tastes in fiction. Our taste in fiction reveals a great deal about who we are, reflecting our values, aspirations, and even our emotional and intellectual tendencies. Fiction serves as a mirror to our inner selves while also shaping our identity and worldview. My answer was Tinker Tailor Soldier Spy by John le Carré’.

John le Carré’s Tinker Tailor Soldier Spy is often celebrated as a masterpiece of espionage fiction, weaving a complex tale of betrayal, loyalty, and meticulous investigation. Surprisingly, the world of George Smiley’s mole hunt within MI6 shares striking parallels with the work of quality professionals. Both domains require precision, analytical thinking, and an unwavering commitment to uncovering flaws in systems.

Shared Traits: Espionage and Quality Assurance

  1. Meticulous Investigation
    In Tinker Tailor Soldier Spy, George Smiley’s task is to uncover a mole embedded within the ranks of MI6. His investigation involves piecing together fragments of information, analyzing patterns, and identifying anomalies—all while navigating layers of secrecy and misdirection. Similarly, quality professionals must scrutinize processes, identify root causes of defects, and ensure systems operate flawlessly. Both roles demand a sharp eye for detail and the ability to connect disparate clues.
  2. Risk Management
    Spycraft often involves operating in high-stakes environments where a single misstep could lead to catastrophic consequences. Smiley’s investigation exemplifies this as he balances discretion with urgency to protect national security. Quality assurance professionals face similar stakes when ensuring product safety or compliance with regulations. A failure in quality can lead to reputational damage or even harm to end-users.
  3. Interpersonal Dynamics
    Espionage relies heavily on understanding human motivations and building trust or exploiting weaknesses. Smiley navigates complex relationships within MI6, some marked by betrayal or hidden agendas. Likewise, quality professionals often work across departments, requiring strong interpersonal skills to foster collaboration and address resistance to change.
  4. Adaptability
    Both spies and quality professionals operate in ever-changing landscapes. For Smiley, this means adapting to new intelligence and countering misinformation. For quality experts, it involves staying updated on industry standards and evolving technologies while responding to unexpected challenges.

Lessons for Quality Professionals from Spy Novels

  1. The Power of Patience
    Smiley’s investigation is not rushed; it is methodical and deliberate. This mirrors the importance of patience in quality assurance—thorough testing and analysis are essential to uncover hidden issues that could compromise outcomes.
  2. Trust but Verify
    In Tinker Tailor Soldier Spy, trust is a fragile commodity. Smiley must verify every piece of information before acting on it. Quality professionals can adopt this mindset by implementing robust verification processes to ensure that assumptions or data are accurate.
  3. Embrace Ambiguity
    Espionage thrives in gray areas where certainty is rare. Similarly, quality assurance often involves navigating incomplete data or ambiguous requirements, requiring professionals to make informed decisions amidst uncertainty.
  4. Continuous Learning
    Intelligence officers must constantly refine their skills to outmaneuver adversaries6. Quality professionals benefit from a similar commitment to learning—whether through adopting new methodologies or staying informed about industry trends.
  5. Collaboration Across Silos
    Just as Smiley relies on allies with diverse expertise during his mole hunt, quality assurance thrives on teamwork across departments.

Themes That Resonate

Spy novels like Tinker Tailor Soldier Spy explore themes of loyalty, duty, and the pursuit of excellence despite systemic challenges. These themes are equally relevant for quality professionals who must uphold standards even when faced with organizational resistance or resource constraints. Both fields underscore the importance of integrity—whether in safeguarding national security or ensuring product reliability.

A Fiction Reading List

I get asked a lot where the name of this blog comes from, and then I have to explain my love of Kafka. This past week, I got asked what a book club would look like.

  1. The Metamorphosis by Franz Kafka
    Kafka’s iconic novella critiques the alienation and dehumanization inherent in modern work, as Gregor Samsa’s transformation into an insect mirrors the loss of identity under corporate systems.
  2. War with the Newts by Karel Čapek
    This satirical novel explores exploitation and capitalism through the enslavement of intelligent newts. It critiques corporate greed and globalization, offering insights into the commodification of labor. It is very timely as you think of the impact of AI.
  3. The Jungle by Upton Sinclair
    Sinclair’s exposé of the meatpacking industry highlights the brutal realities of corporate exploitation and immigrant labor, themes that remain relevant in discussions about workplace ethics today. And are feeling really relevant in today’s political climate in the US.
  4. À la ligne: Feuillets d’usine by Joseph Ponthus
    This poetic novel recounts the author’s experiences as a factory worker, vividly portraying the physical and emotional toll of repetitive labor. It critiques the corporate drive for profit at the expense of human dignity. English version is titled On the Line: Notes from a Factory and was translated by Stephanie Smee.
  5. The Other Black Girl by Zakiya Dalila Harris
    Set in a publishing house, this thriller examines workplace racism, microaggressions, and systemic inequities within corporate environments.
  6. Severance by Ling Ma
    A satirical take on office work and consumerism, this novel critiques the monotony of corporate culture while blending apocalyptic fiction.
  7. The Reader on the 6.27 by Jean-Paul Didierlaurent
    This novel follows a book-pulping machine operator who salvages random pages to read aloud during his commute. It explores tensions between intellectual life and manual labor within a corporate framework.
  8. Infinite Country by Patricia Engel
    This novel examines how immigration policies intersect with labor exploitation, highlighting systemic inequities faced by immigrant workers.

The reading list explores the complex interplay between corporate culture, alienation, and the human condition in modern society. Kafka’s The Metamorphosis and Čapek’s War with the Newts serve as foundational texts, critiquing the dehumanizing effects of capitalism and labor exploitation. Sinclair’s The Jungle exposes the brutal realities of industrial work, while contemporary novels like On the Line by Ponthus and The Other Black Girl by Harris examine the physical and emotional toll of repetitive labor and systemic inequities in corporate environments. French author Ponthus offers unique perspectives on factory work and corporate language, respectively, highlighting the global nature of these issues. The list also includes works that satirize office culture, such as Ling Ma’s Severance, which blends corporate critique with apocalyptic fiction. Throughout these selections, themes of alienation, identity loss, and the struggle for dignity in the face of corporate demands are prevalent, reflecting the ongoing relevance of these issues in modern work life.

The list has French representation, because frankly I started thinking of the list in Toulouse. I’m sure I could come up with a lot more global authors, though it might be hard to stick to 8 or 10 then.

Quality Book Shelf: Mastering Safety Risk Management for Medical and In Vitro Devices

Disclaimer: I have had the privilege of being a former colleague of Jayet’s, and hold him in immense regard.

Mastering Safety Risk Management for Medical and In Vitro Devices by Jayet Moon and Arun Mathew is a comprehensive guide that addresses the critical aspects of risk management in medical and in vitro devices. This book is an essential resource for professionals involved in medical device design, production, and post-market phases, providing a structured approach to ensure product safety and regulatory compliance.

Starting with a solid overview of risk management principles that apply not only to medical devices under ISO13485 but will also teach pharmaceutical folks following ICH Q9 white a bit, this book delivers a heavy dose of knowledge and the benefit of wisdom in applying it.

The book then goes deep into the design assurance process, which is crucial for identifying, understanding, analyzing, and mitigating risks associated with healthcare product design. This foundational approach ensures that practitioners can perform a favorable benefit-risk assessment, which is vital for the safety and efficacy of medical devices.

Strengths

  • Regulatory Compliance: The authors provide detailed guidance on conforming to major international standards such as ISO 13485:2016, ISO 14971:2019, the European Union Medical Device Regulation (MDR), In Vitro Diagnostic Regulation (IVDR), and the US FDA regulations, including the new FDA Quality Management System Regulation (QMSR).
  • Risk Management Tools: The book offers a variety of tools and methodologies for effective risk management. These include risk analysis techniques, risk evaluation methods, and risk control measures, which are explained clearly and practically.
  • Lifecycle Approach: One of the standout features of this book is its lifecycle approach to risk management. It emphasizes that risk management does not end with product design but continues through production and into the post-market phase, ensuring ongoing safety and performance.

The authors, Jayet Moon and Arun Mathew, bring their extensive experience in the field to bear, providing real-world examples and case studies that illustrate the application of risk management principles in various scenarios. This practical approach helps readers to understand how to implement the theoretical concepts discussed in the book. This book is essential for anyone working in medical devices and a good read for other quality life sciences professionals as there is much to draw on here.