Profound Knowledge

In his System of Profound Knowledge, Deming provides a framework based on a deep and comprehensive understanding of a subject or system that goes beyond surface-level information to provide a holistic approach to leadership and management.

Profound knowledge is central to a quality understanding as it is the ability to deeply understand an organization or its critical processes, delving beneath surface-level observations to uncover fundamental principles and truths. This knowledge is a guiding force for daily living, shaping one’s thinking and values, ultimately manifesting in their conduct. It embodies wisdom, morality, and deep insight, offering a comprehensive framework for understanding complex systems and making informed decisions. Profound knowledge goes beyond mere facts or data, encompassing a holistic view that allows individuals to navigate challenges and drive meaningful improvements within their organizations and personal lives.

Components of Deming’s System of Profound Knowledge

Deming’s SoPK consists of four interrelated components:

Appreciation for a System: Understanding how different parts of an organization interact and work together as a whole system.
Knowledge about Variation: Recognizing that variation exists in all processes and systems, and understanding how to interpret and manage it.
Theory of Knowledge: Understanding how we learn and gain knowledge, including the importance of prediction and testing theories.
Psychology: Understanding human behavior, motivation, and interactions within an organization.

Applications of Profound Knowledge

Organizational Transformation: Profound knowledge provides a framework for improving and transforming systems.
Decision Making: It helps leaders make more informed decisions by providing a comprehensive lens through which to view organizational issues.
Continuous Improvement: The SoPK promotes ongoing learning and refinement of processes.
Leadership Development: It transforms managers into leaders by providing a new perspective on organizational management.

Profound knowledge, as conceptualized by Deming, provides a comprehensive framework for understanding and improving complex systems, particularly in organizational and management contexts. It encourages a holistic view that goes beyond subject-matter expertise to foster true transformation and continuous improvement.

Depth and Comprehensiveness

Profound knowledge goes beyond surface-level understanding or mere subject matter expertise. It provides a deep, fundamental understanding of systems, principles, and underlying truths. While regular knowledge might focus on facts or specific skills, profound knowledge seeks to understand the interconnections and root causes within a system.

Holistic Perspective

Profound knowledge takes a holistic approach to understanding and improving systems. It consists of four interrelated components:

Appreciation for a system
Knowledge about variation
Theory of knowledge
Psychology

These components work together to provide a comprehensive framework for understanding complex systems, especially in organizational contexts.

Interdisciplinary Nature

Profound knowledge often transcends traditional disciplinary boundaries. It combines insights from various fields, such as systems thinking, psychology, and epistemology, to create a more comprehensive understanding of complex phenomena.

Focus on Improvement and Optimization

While regular knowledge might be sufficient for maintaining the status quo, profound knowledge is geared towards improvement and optimization of systems. It provides a framework for understanding how to make meaningful changes and improvements in organizations and processes.

Knowledge as Object or Social Action

Deming’s System of Profound Knowledge can be easily seen as an application of knowledge as social action.

The concept of knowledge as object versus knowledge as social action represents two distinct perspectives on the nature and function of knowledge in society. This dichotomy, rooted in sociological theory, offers contrasting views on how knowledge is created, understood, and utilized. Knowledge as object refers to the traditional view of knowledge as a static, codified entity that can be possessed, stored, and transferred independently of social context. In contrast, knowledge as social action emphasizes the dynamic, socially constructed nature of knowledge, viewing it as an active process embedded in social interactions and practices. This distinction, largely developed through the work of sociologists like Karl Mannheim, challenges us to consider how our understanding of knowledge shapes our approach to learning, decision-making, and social organization.

Knowledge as Object

Knowledge as object refers to knowledge as a static, codified entity that can be possessed, stored, and transferred. Key aspects include:

Knowledge is seen as propositional or factual information that can be articulated and recorded. For example, knowledge stored in documents or expert systems.
It involves an awareness of facts, familiarity with situations, or practical skills that an individual possesses.
Knowledge is often characterized as justified true belief – a belief that is both true and justified.
It can be understood as a cognitive state of an individual person.
Knowledge as object aligns with more traditional, rationalist views of knowledge as something that can be objectively defined and measured.

Knowledge as Social Action

Knowledge as social action views knowledge as an active, dynamic process that is socially constructed. Key aspects include:

Knowledge is produced through social interactions, relationships and collective processes rather than being a static entity.
It emphasizes how knowledge is created, shared and applied in social contexts.
Social action theories examine the motives and meanings of individuals as they engage in knowledge-related behaviors.
Knowledge is seen as emerging from and being shaped by social, cultural and historical contexts.
It focuses on knowledge as a process of knowing rather than a fixed object.
This view aligns with social constructivist and pragmatist perspectives on knowledge.

Key Differences

Static vs. Dynamic: Knowledge as object is fixed and stable, while knowledge as social action is fluid and evolving.
Individual vs. Collective: The object view focuses on individual cognition, while the social action view emphasizes collective processes.
Product vs. Process: Knowledge as object treats knowledge as an end product, while social action views it as an ongoing process.
Context-independent vs. Context-dependent: The object view assumes knowledge can be decontextualized, while social action emphasizes situatedness.
Possession vs. Practice: Knowledge as object can be possessed, while knowledge as social action is enacted through practices.

Knowledge as object reflects a more traditional, cognitive view of knowledge as factual information possessed by individuals. In contrast, knowledge as social action emphasizes the dynamic, socially constructed nature of knowledge as it is created and applied in social contexts. Both perspectives offer valuable insights into the nature of knowledge, with the social action view gaining prominence in fields like sociology of knowledge and science studies.

Knowledge sharing as a form of social action plays a crucial role in modern organizations, influencing various aspects of organizational life and performance. Here’s an analysis of how knowledge as social action manifests in contemporary organizations:

Knowledge Sharing as a Social Process

In organizations knowledge sharing is increasingly viewed as a social process rather than a simple transfer of information. This perspective emphasizes:

The interactive nature of knowledge exchange
The importance of relationships and trust in facilitating sharing
The role of organizational culture in promoting or hindering knowledge flow

Knowledge sharing becomes a form of social action when employees actively engage in exchanging ideas, experiences, and expertise with their colleagues.

Impact on Organizational Culture

Knowledge sharing as social action can significantly shape organizational culture by:

Fostering a climate of openness and collaboration
Encouraging continuous learning and innovation
Building trust and strengthening interpersonal relationships

Organizations that successfully implement knowledge sharing practices often see a shift towards a more transparent and cooperative work environment.

Enhancing Employee Engagement

When knowledge sharing is embraced as a social action, it can boost employee engagement by:

Making employees feel valued for their expertise and contributions
Increasing their sense of belonging and connection to the organization
Empowering them with information to make better decisions

Engaged employees are more likely to participate in knowledge sharing activities, creating a virtuous cycle of engagement and collaboration.

Driving Innovation and Performance

Knowledge as social action can be a powerful driver of innovation and organizational performance:

It facilitates the cross-pollination of ideas across departments
It helps in identifying and solving problems more efficiently
It reduces duplication of efforts and promotes best practices

By leveraging collective knowledge through social interactions, organizations can enhance their problem-solving capabilities and competitive advantage.

Challenges and Considerations

While knowledge sharing as social action offers numerous benefits, organizations may face challenges in implementing and sustaining such practices:

Overcoming knowledge hoarding behaviors
Addressing power dynamics that may hinder open sharing
Ensuring equitable access to knowledge across the organization

Leaders play a crucial role in addressing these challenges by modeling knowledge sharing behaviors and creating supportive structures.

Technology as an Enabler

Modern organizations often leverage technology to facilitate knowledge sharing as a social action:

Knowledge management systems
Collaborative platforms and social intranets
Virtual communities of practice

These tools can help break down geographical and hierarchical barriers to knowledge flow, enabling more dynamic and inclusive sharing practices.

Psychological Safety and Knowledge Sharing

The concept of psychological safety is closely tied to knowledge sharing as social action:

A psychologically safe environment encourages risk-taking in interpersonal interactions
It reduces fear of negative consequences for sharing ideas or admitting mistakes
It promotes open communication and collective learning

Organizations that foster psychological safety are more likely to see robust knowledge sharing practices among their employees.

Viewing knowledge sharing as a form of social action in organizations highlights its transformative potential. It goes beyond mere information exchange to become a catalyst for cultural change, employee engagement, and organizational innovation. By recognizing and nurturing the social aspects of knowledge sharing, organizations can create more dynamic, adaptive, and high-performing work environments.

Unlocking Hidden Potential: The Art of Assessing Team Capability

For managers in an organization it is critical to understand and nurture the capabilities of our team members. I spend a lot of time on this blog talking about capability and competence frankly because they are an elusive concept, invisible to the naked eye. We can only perceive it through its manifestations – the tangible outputs and results produced by our team. This presents a unique challenge: how do we accurately gauge a team member’s highest level of capability?

The Evidence-Based Approach

The key to unraveling this mystery lies in evidence. We must adopt a systematic, iterative approach to testing and challenging our team members through carefully designed project work. This method allows us to gradually uncover the true extent of their competence.

Step 1: Initial Assessment

The journey begins with a quick assessment of the team member’s current applied capability. This involves examining the fruits of their labor – the tangible outcomes of their work. As managers, we must rely on our intuitive judgment to evaluate these results. I strongly recommend this is a conversation with the individual as well.

Step 2: Incremental Complexity

Once we have established a baseline, the next step is to marginally increase the complexity of the task. This takes the form of a new project, slightly more challenging than the previous one. Crucially, we must promise a project debrief upon completion. This debrief serves as a valuable learning opportunity for both the team member and the manager.

Step 3: Continuous Iteration

If the project is successful, it becomes a springboard for the next challenge. We continue this process, incrementally increasing the complexity with each new project, always ensuring a debrief follows. This cycle persists until we reach a point of failure.

The Point of Failure: A Revelatory Moment

When a team member encounters failure, we gain invaluable insights into their competence. This moment of truth illuminates both their strengths and limitations. We now have a clearer understanding of where they excel and where they struggle.

However, this is not the end of the journey. After allowing some time for reflection and growth, we must challenge them again. This process of continual challenge and assessment should persist throughout the team member’s tenure with the organization.

The Role of Deliberate Practice

This approach aligns closely with the concept of deliberate practice, which is fundamental to the development of expertise. By providing our team members with guided practice, observation opportunities, problem-solving challenges, and experimentation, we create an environment conducive to skill development.

Building Competence

Remember, competence is a combination of capability and skill. While we cannot directly observe capability, we can nurture it through this process of continual challenge and assessment. By doing so, we also develop the skill component, as team members gain more opportunities for practice.

The Manager’s Toolkit

To effectively implement this approach, managers should cultivate several key attributes:

System thinking: Understanding the interdependencies within projects and anticipating consequences.
Judgment: Making rapid, wise decisions about when to increase complexity.
Context awareness: Taking into account the unique circumstances of each team member and project.
Interpersonal skills: Motivating and leading team members through challenges.
Communication: Constructing and delivering clear, persuasive messages about project goals and expectations.

By embracing this evidence-based, iterative approach to assessing capability, managers can unlock the hidden potential within their teams. It’s a continuous journey of discovery, challenge, and growth – one that benefits both the individual team members and the organization as a whole.

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.”

Voluntary Standard Organizations and You

A consensus standards organization, also known as a voluntary consensus standards body, is an entity that develops and publishes technical standards through a collaborative, consensus-based process involving various stakeholders. Here are the key characteristics of consensus standards organizations:

Voluntary participation: Involvement in the standards development process is voluntary for interested parties.
Consensus-based approach: Standards are developed through a process that seeks general agreement among participants, considering the views of all parties and reconciling conflicting arguments.
Openness: The procedures and processes for developing standards are open to interested parties, providing meaningful opportunities for participation on a non-discriminatory basis.
Balance: The standards development process aims to achieve balance among different stakeholder groups, ensuring no single interest dominates.
Due process: The organization follows established procedures that include provisions for appeals and addressing objections.
Transparency: The procedures for developing standards and the standards themselves are transparent and accessible.
Non-profit status: Many consensus standards organizations operate as non-profit entities.
Diverse stakeholder involvement: Participants typically include industry experts, government representatives, academics, and consumer groups.
Accreditation: In some cases, these organizations may be accredited by national bodies (e.g., ANSI in the United States) to ensure they follow proper procedures.
Wide range of applications: Consensus standards can cover various fields, including product specifications, testing methods, management systems, and more.

Examples of well-known consensus standards organizations include:

International Organization for Standardization (ISO)
American National Standards Institute (ANSI)
ASTM International (formerly American Society for Testing and Materials)
British Standards Institution (BSI)

These organizations play a crucial role in promoting quality, safety, and interoperability across various industries and sectors by developing widely accepted standards through collaborative processes.

The Unique Role of Inter-Governmental Agencies in Pharmaceutical Standards

While discussing consensus standard organizations, it’s important to highlight a distinct category that operates similarly but doesn’t quite fit the traditional mold: inter-governmental agencies like the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and the Pharmaceutical Inspection Co-operation Scheme (PIC/S).

These organizations share some key characteristics with consensus standard bodies:

They focus on harmonization efforts in the pharmaceutical industry.
They operate internationally, involving multiple countries and regulatory authorities.
They provide frameworks for collaboration among stakeholders.

However, ICH and PIC/S differ from typical consensus standard organizations in several ways:

Membership: They primarily comprise regulatory authorities rather than a broad range of industry stakeholders.
Authority: While not legally binding, their guidelines and standards often carry significant weight with regulatory bodies worldwide.

These organizations play a crucial role in shaping global pharmaceutical regulations, bridging the gap between formal regulatory requirements and industry-led standards. Their work complements that of traditional consensus standard organizations, contributing to a more cohesive and harmonized global regulatory environment for pharmaceuticals.

Good Engineering Practices Under ASTM E2500

ASTM E2500 recognizes that Good Engineering Practices (GEP) are essential for pharmaceutical companies to ensure the consistent and reliable design, delivery, and operation of engineered systems in a manner suitable for their intended purpose.

Key Elements of Good Engineering Practices

Risk Management: Applying systematic processes to identify, assess, and control risks throughout the lifecycle of engineered systems. This includes quality risk management focused on product quality and patient safety.
Cost Management: Estimating, budgeting, monitoring and controlling costs for engineering projects and operations. This helps ensure projects deliver value and stay within budget constraints.
Organization and Control: Establishing clear organizational structures, roles and responsibilities for engineering activities. Implementing monitoring and control mechanisms to track performance.
Innovation and Continual Improvement: Fostering a culture of innovation and continuous improvement in engineering processes and systems.
Lifecycle Management: Applying consistent processes for change management, issue management, and document control throughout a system’s lifecycle from design to decommissioning.
Project Management: Following structured approaches for planning, executing and controlling engineering projects.
Design Practices: Applying systematic processes for requirements definition, design development, review and qualification.
Operational Support: Implementing asset management, calibration, maintenance and other practices to support systems during routine operations.

Key Steps for Implementation

Develop and document GEP policies, procedures and standards tailored to the company’s needs
Establish an Engineering Quality Process (EQP) to link GEP to the overall Pharmaceutical Quality System
Provide training on GEP principles and procedures to engineering staff
Implement risk-based approaches to focus efforts on critical systems and processes
Use structured project management methodologies for capital projects
Apply change control and issue management processes consistently
Maintain engineering documentation systems with appropriate controls
Conduct periodic audits and reviews of GEP implementation
Foster a culture of quality and continuous improvement in engineering
Ensure appropriate interfaces between engineering and quality/regulatory functions

The key is to develop a systematic, risk-based approach to GEP that is appropriate for the company’s size, products and operations. When properly implemented, GEP provides a foundation for regulatory compliance, operational efficiency and product quality in pharmaceutical manufacturing.

Invest in a Living, Breathing Engineering Quality Process (EQP)

The EQP establishes the formal connection between GEP and the Pharmaceutical Quality System it resides within, serving as the boundary between Quality oversight and engineering activities, particularly for implementing Quality Risk Management (QRM) based integrated Commissioning and Qualification (C&Q).

It should also provide an interface between engineering activities and other systems like business operations, health/safety/environment, or other site quality systems.

Based on the information provided in the document, here is a suggested table of contents for an Engineering Quality Process (EQP):

Table of Contents – Engineering Quality Process (EQP)

Introduction
1.1 Purpose
1.2 Scope
1.3 Definitions
Application and Context
2.1 Relationship to Pharmaceutical Quality System (PQS)
2.2 Relationship to Good Engineering Practice (GEP)
2.3 Interface with Quality Risk Management (QRM)
EQP Elements
3.1 Policies and Procedures for the Asset Lifecycle and GEPs
3.2 Risk Assessment
3.3 Change Management
3.4 Document Control
3.5 Training
3.6 Auditing
Deliverables
4.1 GEP Documentation
4.2 Risk Assessments
4.3 Change Records
4.4 Training Records
4.5 Audit Reports
Roles and Responsibilities
5.1 Engineering
5.2 Quality
5.3 Operations
5.4 Other Stakeholders
EQP Implementation
6.1 Establishing the EQP
6.2 Maintaining the EQP
6.3 Continuous Improvement
References
Appendices