The Discretionary Deficit: Why Job Descriptions Fail to Capture the Real Work of Quality

Job descriptions are foundational documents in pharmaceutical quality systems. Regulations like 21 CFR 211.25 require that personnel have appropriate education, training, and experience to perform assigned functions. The job description serves as the starting point for determining training requirements, establishing accountability, and demonstrating regulatory compliance. Yet for all their regulatory necessity, most job descriptions fail to capture what actually makes someone effective in their role.

The problem isn’t that job descriptions are poorly written or inadequately detailed. The problem is more fundamental: they describe static snapshots of isolated positions while ignoring the dynamic, interconnected, and discretionary nature of real organizational work.

The Static Job Description Trap

Traditional job descriptions treat roles as if they exist in isolation. A quality manager’s job description might list responsibilities like “lead inspection readiness activities,” “participate in vendor management,” or “write and review deviations and CAPAs”. These statements aren’t wrong, but they’re profoundly incomplete.

Elliott Jacques, a late 20th century thinker on organizational theory, identified a critical distinction that most job descriptions ignore: the difference between prescribed elements and discretionary elements of work. Every role contains both, yet our documentation acknowledge only one.

Prescribed elements are the boundaries, constraints, and requirements that eliminate choice. They specify what must be done, what cannot be done, and the regulations, policies, and methods to which the role holder must conform. In pharmaceutical quality, prescribed elements are abundant and well-documented: follow GMPs, complete training before performing tasks, document decisions according to procedure, escalate deviations within defined timeframes.

Discretionary elements are everything else—the choices, judgments, and decisions that cannot be fully specified in advance. They represent the exercise of professional judgment within the prescribed limits. Discretion is where competence actually lives.

When we investigate a deviation, the prescribed elements are clear: follow the investigation procedure, document findings in the system, complete within regulatory timelines. But the discretionary elements determine whether the investigation succeeds: What questions should I ask? Which subject matter experts should I engage? How deeply should I probe this particular failure mode? What level of evidence is sufficient? When have I gathered enough data to draw conclusions?

As Jacques observed, “the core of industrial work is therefore not only to carry out the prescribed elements of the job, but also to exercise discretion in its execution”. Yet if job descriptions don’t recognize and define the limits of discretion, employees will either fail to exercise adequate discretion or wander beyond appropriate limits into territory that belongs to other roles.

The Interconnectedness Problem

Job descriptions also fail because they treat positions as independent entities rather than as nodes in an organizational network. In reality, all jobs in pharmaceutical organizations are interconnected. A mistake in manufacturing manifests as a quality investigation. A poorly written procedure creates training challenges. An inadequate risk assessment during tech transfer generates compliance findings during inspection.

This interconnectedness means that describing any role in isolation fundamentally misrepresents how work actually flows through the organization. When I write about process owners, I emphasize that they play a fundamental role in managing interfaces between key processes precisely to prevent horizontal silos. The process owner’s authority and accountability extend across functional boundaries because the work itself crosses those boundaries.

Yet traditional job descriptions remain trapped in functional silos. They specify reporting relationships vertically—who you report to, who reports to you—but rarely acknowledge the lateral dependencies that define how work actually gets done. They describe individual accountability without addressing mutual obligations.

The Missing Element: Mutual Role Expectations

Jacques argued that effective job descriptions must contain three elements:

The central purpose and rationale for the position
The prescribed and discretionary elements of the work
The mutual role expectations—what the focal role expects from other roles, and vice versa

That third element is almost entirely absent from job descriptions, yet it’s arguably the most critical for organizational effectiveness.

Consider a deviation investigation. The person leading the investigation needs certain things from other roles: timely access to manufacturing records from operations, technical expertise from subject matter experts, root cause methodology support from quality systems specialists, regulatory context from regulatory affairs. Conversely, those other roles have legitimate expectations of the quality professional: clear articulation of information needs, respect for operational constraints, transparency about investigation progress, appropriate use of their expertise.

These mutual expectations form the actual working contract that determines whether the organization functions effectively. When they remain implicit and undocumented, we get the dysfunction I see constantly: investigations that stall because operations claims they’re too busy to provide information, subject matter experts who feel blindsided by last-minute requests, quality professionals frustrated that other functions don’t understand the urgency of compliance timelines.

Decision-making frameworks like DACI and RAPID exist precisely to make these mutual expectations explicit. They clarify who drives decisions, who must be consulted, who has approval authority, and who needs to be informed. But these frameworks work at the decision level. We need the same clarity at the role level, embedded in how we define positions from the start.

Discretion and Hierarchy

The amount of discretion in a role—what Jacques called the “time span of discretion”—is actually a better measure of organizational level than traditional hierarchical markers like job titles or reporting relationships. A front-line operator works within tightly prescribed limits with short time horizons: follow this batch record, use these materials, execute these steps, escalate these deviations immediately. A site quality director operates with much broader discretion over longer time horizons: establish quality strategy, allocate resources across competing priorities, determine which regulatory risks to accept or mitigate, shape organizational culture over years.

This observation has profound implications for how we think about organizational design. As I’ve written before, the idea that “the higher the rank in the organization the more decision-making authority you have” is absurd. In every organization I’ve worked in, people hold positions of authority over areas where they lack the education, experience, and training to make competent decisions.

The solution isn’t to eliminate hierarchy—organizations need stratification by complexity and time horizon. The solution is to separate positional authority from decision authority and to explicitly define the discretionary scope of each role.

A manufacturing supervisor might have positional authority over operations staff but should not have decision authority over validation strategies—that’s outside their discretionary scope. A quality director might have positional authority over the quality function but should not unilaterally decide equipment qualification approaches that require deep engineering expertise. Clear boundaries around discretion prevent the territorial conflicts and competence gaps that plague organizations.

Implications for Training and Competency

The distinction between prescribed and discretionary elements has critical implications for how we develop competency. Most pharmaceutical training focuses almost exclusively on prescribed elements: here’s the procedure, here’s how to use the system, here’s what the regulation requires. We measure training effectiveness by knowledge checks that assess whether people remember the prescribed limits.

But competence isn’t about following procedures—it’s about exercising appropriate judgment within procedural constraints. It’s about knowing what to do when things depart from expectations, recognizing which risk assessment methodology fits a particular decision context, sensing when additional expertise needs to be consulted.

These discretionary capabilities develop differently than procedural knowledge. They require practice, feedback, coaching, and sustained engagement over time. A meta-analysis examining skill retention found that complex cognitive skills like risk assessment decay much faster than simple procedural skills. Without regular practice, the discretionary capabilities that define competence actively degrade.

This is why I emphasize frequency, duration, depth, and accuracy of practice as the real measures of competence. It’s why deep process ownership requires years of sustained engagement rather than weeks of onboarding. It’s why competency frameworks must integrate skills, knowledge, and behaviors in ways that acknowledge the discretionary nature of professional work.

Job descriptions that specify only prescribed elements provide no foundation for developing the discretionary capabilities that actually determine whether someone can perform the role effectively. They lead to training plans focused on knowledge transfer rather than judgment development, performance evaluations that measure compliance rather than contribution, and hiring decisions based on credentials rather than capacity.

Designing Better Job Descriptions

Quality leaders—especially those of us responsible for organizational design—need to fundamentally rethink how we define and document roles. Effective job descriptions should:

Articulate the central purpose. Why does this role exist? What job is the organization hiring this position to do? A deviation investigator exists to transform quality failures into organizational learning while demonstrating control to regulators. A validation engineer exists to establish documented evidence that systems consistently produce quality outcomes. Purpose provides the context for exercising discretion appropriately.
Specify prescribed boundaries explicitly. What are the non-negotiable constraints? Which policies, regulations, and procedures must be followed without exception? What decisions require escalation or approval? Clear prescribed limits create safety—they tell people where they can’t exercise judgment and where they must seek guidance.
Define discretionary scope clearly. Within the prescribed limits, what decisions is this role expected to make independently? What level of evidence is this role qualified to evaluate? What types of problems should this role resolve without escalation? How much resource commitment can this role authorize? Making discretion explicit transforms vague “good judgment” expectations into concrete accountability.
Document mutual role expectations. What does this role need from other roles to be successful? What do other roles have the right to expect from this position? How do the prescribed and discretionary elements of this role interface with adjacent roles in the process? Mapping these interdependencies makes the organizational system visible and manageable.
Connect to process roles explicitly. Rather than generic statements like “participate in CAPAs,” job descriptions should specify process roles: “Author and project manage CAPAs for quality system improvements” or “Provide technical review of manufacturing-related CAPAs”. Process roles define the specific prescribed and discretionary elements relevant to each procedure. They provide the foundation for role-based training curricula that address both procedural compliance and judgment development.

Beyond Job Descriptions: Organizational Design

The limitations of traditional job descriptions point to larger questions about organizational design. If we’re serious about building quality systems that work—that don’t just satisfy auditors but actually prevent failures and enable learning—we need to design organizations around how work flows rather than how authority is distributed.

This means establishing empowered process owners who have clear authority over end-to-end processes regardless of functional boundaries. It means implementing decision-making frameworks that explicitly assign decision roles based on competence rather than hierarchy. It means creating conditions for deep process ownership through sustained engagement rather than rotational assignments.

Most importantly, it means recognizing that competent performance requires both adherence to prescribed limits and skillful exercise of discretion. Training systems, performance management approaches, and career development pathways must address both dimensions. Job descriptions that acknowledge only one while ignoring the other set employees up for failure and organizations up for dysfunction.

The Path Forward

Jacques wrote that organizational structures should be “requisite”—required by the nature of work itself rather than imposed by arbitrary management preferences. There’s wisdom in that framing for pharmaceutical quality. Our organizational structures should emerge from the actual requirements of pharmaceutical work: the need for both compliance and innovation, the reality of interdependent processes, the requirement for expert judgment alongside procedural discipline.

Job descriptions are foundational documents in quality systems. They link to hiring decisions, training requirements, performance expectations, and regulatory demonstration of competence. Getting them right matters not just for audit preparedness but for organizational effectiveness.

The next time you review a job description, ask yourself: Does this document acknowledge both what must be done and what must be decided? Does it clarify where discretion is expected and where it’s prohibited? Does it make visible the interdependencies that determine whether this role can succeed? Does it provide a foundation for developing both procedural compliance and professional judgment?

If the answer is no, you’re not alone. Most job descriptions fail these tests. But recognizing the deficit is the first step toward designing organizational systems that actually match the complexity and interdependence of pharmaceutical work—systems where competence can develop, accountability is clear, and quality is built into how we organize rather than inspected into what we produce.

The work of pharmaceutical quality requires us to exercise discretion well within prescribed limits. Our organizational design documents should acknowledge that reality rather than pretend it away.

Example Job Description

Site Quality Risk Manager – Seattle and Redmond Sites

Reports To: Sr. Manager, Quality
Department: Qualty
Location: Hybrid/Field-Based – Certain Sites

Purpose of the Role

The Site Quality Risk Manager ensures that quality and manufacturing operations at the sites maintain proactive, compliant, and science-based risk management practices. The role exists to translate uncertainty into structured understanding—identifying, prioritizing, and mitigating risks to product quality, patient safety, and business continuity. Through expert application of Quality Risk Management (QRM) principles, this role builds a culture of curiosity, professional judgment, and continuous improvement in decision-making.

Prescribed Work Elements

Boundaries and required activities defined by regulations, procedures, and PQS expectations.

Ensure full alignment of the site Risk Program with the Corporate Pharmaceutical Quality System (PQS), ICH Q9(R1) principles, and applicable GMP regulations.
Facilitate and document formal quality risk assessments for manufacturing, laboratory, and facility operations.
Manage and maintain the site Risk Registers for sitefacilities.
Communicate high-priority risks, mitigation actions, and risk acceptance decisions to site and functional senior management.
Support Health Authority inspections and audits as QRM Subject Matter Expert (SME).
Lead deployment and sustainment of QRM process tools, templates, and governance structures within the corporate risk management framework.
Maintain and periodically review site-level guidance documents and procedures on risk management.

Discretionary Work Elements

Judgment and decision-making required within professional and policy boundaries.

Determine the appropriate depth and scope of risk assessments based on formality and system impact.
Evaluate the adequacy and proportionality of mitigations, balancing regulatory conservatism with operational feasibility.
Prioritize site risk topics requiring cross-functional escalation or systemic remediation.
Shape site-specific applications of global QRM tools (e.g., HACCP, FMEA, HAZOP, RRF) to reflect manufacturing complexity and lifecycle phase—from Phase 1 through PPQ and commercial readiness.
Determine which emerging risks require systemic visibility in the Corporate Risk Register and document rationale for inclusion or deferral.
Facilitate reflection-based learning after deviations, applying risk communication as a learning mechanism across functions.
Offer informed judgment in gray areas where quality principles must guide rather than prescribe decisions.

Mutual Role Expectations

From the Site Quality Risk Manager:

Partner transparently with Process Owners and Functional SMEs to identify, evaluate, and mitigate risks.
Translate technical findings into business-relevant risk statements for senior leadership.
Mentor and train site teams to develop risk literacy and discretionary competence—the ability to think, not just comply.
Maintain a systems perspective that integrates manufacturing, analytical, and quality operations within a unified risk framework.

From Other Roles Toward the Site Quality Risk Manager:

Provide timely, complete data for risk assessments.
Engage in collaborative dialogue rather than escalation-only interactions.
Respect QRM governance boundaries while contributing specialized technical judgment.
Support implementation of sustainable mitigations beyond short-term containment.

Qualifications and Experience

Bachelor’s degree in life sciences, engineering, or a related technical discipline. Equivalent experience accepted.
Minimum 4+ years relevant experience in Quality Risk Management within biopharmaceutical GMP manufacturing environments.
Demonstrated application of QRM methodologies (FMEA, HACCP, HAZOP, RRF) and facilitation of cross-functional risk assessments.
Strong understanding of ICH Q9(R1) and FDA/EMA risk management expectations.
Proven ability to make judgment-based decisions under regulatory and operational uncertainty.
Experience mentoring or building risk capabilities across technical teams.
Excellent communication, synthesis, and facilitation skills.

Purpose in Organizational Design Context

This role exemplifies a requisite position—where scope of discretion, not hierarchy, defines level of work. The Site Quality Risk Manager operates with a medium-span time horizon (6–18 months), balancing regulatory compliance with strategic foresight. Success is measured by the organization’s capacity to detect, understand, and manage risk at progressively earlier stages of product and process lifecycle—reducing reactivity and enabling resilience.

Competency Development and Training Focus

Prescribed competence: Deep mastery of PQS procedures, regulatory standards, and risk methodologies.
Discretionary competence: Situational judgment, cross-functional influence, systems thinking, and adaptive decision-making.
Training plans should integrate practice, feedback, and reflection mechanisms rather than static knowledge transfer, aligning with the competency framework principles.

This enriched job description demonstrates how clarity of purpose, articulation of prescribed vs. discretionary elements, and defined mutual expectations transform a standard compliance document into a true instrument of organizational design and leadership alignment.

Building a Competency Framework for Quality Professionals as System Gardeners

Quality management requires a sophisticated blend of skills that transcend traditional audit and compliance approaches. As organizations increasingly recognize quality systems as living entities rather than static frameworks, quality professionals must evolve from mere enforcers to nurturers—from auditors to gardeners. This paradigm shift demands a new approach to competency development that embraces both technical expertise and adaptive capabilities.

Building Competencies: The Integration of Skills, Knowledge, and Behavior

A comprehensive competency framework for quality professionals must recognize that true competency is more than a simple checklist of abilities. Rather, it represents the harmonious integration of three critical elements: skills, knowledge, and behaviors. Understanding how these elements interact and complement each other is essential for developing quality professionals who can thrive as “system gardeners” in today’s complex organizational ecosystems.

The Competency Triad

Competencies can be defined as the measurable or observable knowledge, skills, abilities, and behaviors critical to successful job performance. They represent a holistic approach that goes beyond what employees can do to include how they apply their capabilities in real-world contexts.

Knowledge: The Foundation of Understanding

Knowledge forms the theoretical foundation upon which all other aspects of competency are built. For quality professionals, this includes:

Comprehension of regulatory frameworks and compliance requirements
Understanding of statistical principles and data analysis methodologies
Familiarity with industry-specific processes and technical standards
Awareness of organizational systems and their interconnections

Knowledge is demonstrated through consistent application to real-world scenarios, where quality professionals translate theoretical understanding into practical solutions. For example, a quality professional might demonstrate knowledge by correctly interpreting a regulatory requirement and identifying its implications for a manufacturing process.

Skills: The Tools for Implementation

Skills represent the practical “how-to” abilities that quality professionals use to implement their knowledge effectively. These include:

Technical skills like statistical process control and data visualization
Methodological skills such as root cause analysis and risk assessment
Social skills including facilitation and stakeholder management
Self-management skills like prioritization and adaptability

Skills are best measured through observable performance in relevant contexts. A quality professional might demonstrate skill proficiency by effectively facilitating a cross-functional investigation meeting that leads to meaningful corrective actions.

Behaviors: The Expression of Competency

Behaviors are the observable actions and reactions that reflect how quality professionals apply their knowledge and skills in practice. These include:

Demonstrating curiosity when investigating deviations
Showing persistence when facing resistance to quality initiatives
Exhibiting patience when coaching others on quality principles
Displaying integrity when reporting quality issues

Behaviors often distinguish exceptional performers from average ones. While two quality professionals might possess similar knowledge and skills, the one who consistently demonstrates behaviors aligned with organizational values and quality principles will typically achieve superior results.

Building an Integrated Competency Development Approach

To develop well-rounded quality professionals who embody all three elements of competency, organizations should:

Map the Competency Landscape: Create a comprehensive inventory of the knowledge, skills, and behaviors required for each quality role, categorized by proficiency level.
Implement Multi-Modal Development: Recognize that different competency elements require different development approaches:
- Knowledge is often best developed through structured learning, reading, and formal education
- Skills typically require practice, coaching, and experiential learning
- Behaviors are shaped through modeling, feedback, and reflective practice
Assess Holistically: Develop assessment methods that evaluate all three elements:
- Knowledge assessments through tests, case studies, and discussions
- Skill assessments through demonstrations, simulations, and work products
- Behavioral assessments through observation, peer feedback, and self-reflection
Create Developmental Pathways: Design career progression frameworks that clearly articulate how knowledge, skills, and behaviors should evolve as quality professionals advance from foundational to leadership roles.

By embracing this integrated approach to competency development, organizations can nurture quality professionals who not only know what to do and how to do it, but who also consistently demonstrate the behaviors that make quality initiatives successful. These professionals will be equipped to serve as true “system gardeners,” cultivating environments where quality naturally flourishes rather than merely enforcing compliance with standards.

Understanding the Four Dimensions of Professional Skills

A comprehensive competency framework for quality professionals should address four fundamental skill dimensions that work in harmony to create holistic expertise:

Technical Skills: The Roots of Quality Expertise

Technical skills form the foundation upon which all quality work is built. For quality professionals, these specialized knowledge areas provide the essential tools needed to assess, measure, and improve systems.

Examples for Quality Gardeners:

Mastery of statistical process control and data analysis methodologies
Deep understanding of regulatory requirements and compliance frameworks
Proficiency in quality management software and digital tools
Knowledge of industry-specific technical processes (e.g., aseptic processing, sterilization validation, downstream chromatography)

Technical skills enable quality professionals to diagnose system health with precision—similar to how a gardener understands soil chemistry and plant physiology.

Methodological Skills: The Framework for System Cultivation

Methodological skills represent the structured approaches and techniques that quality professionals use to organize their work. These skills provide the scaffolding that supports continuous improvement and systematic problem-solving.

Examples for Quality Gardeners:

Application of problem solving methodologies
Risk management framework, methodology and and tools
Design and execution of effective audit programs
Knowledge management to capture insights and lessons learned

As gardeners apply techniques like pruning, feeding, and crop rotation, quality professionals use methodological skills to cultivate environments where quality naturally thrives.

Social Skills: Nurturing Collaborative Ecosystems

Social skills facilitate the human interactions necessary for quality to flourish across organizational boundaries. In living quality systems, these skills help create an environment where collaboration and improvement become cultural norms.

Examples for Quality Gardeners:

Coaching stakeholders rather than policing them
Facilitating cross-functional improvement initiatives
Mediating conflicts around quality priorities
Building trust through transparent communication
Inspiring leadership that emphasizes quality as shared responsibility

Just as gardeners create environments where diverse species thrive together, quality professionals with strong social skills foster ecosystems where teams naturally collaborate toward excellence.

Self-Skills: Personal Adaptability and Growth

Self-skills represent the quality professional’s ability to manage themselves effectively in dynamic environments. These skills are especially crucial in today’s volatile and complex business landscape.

Examples for Quality Gardeners:

Adaptability to changing regulatory landscapes and business priorities
Resilience when facing resistance to quality initiatives
Independent decision-making based on principles rather than rules
Continuous personal development and knowledge acquisition
Working productively under pressure

Like gardeners who must adapt to changing seasons and unexpected weather patterns, quality professionals need strong self-management skills to thrive in unpredictable environments.

Dimension	Definition	Examples	Importance
Technical Skill	Referring to the specialized knowledge and practical skills	– Mastering data analysis – Understanding aseptic processing or freeze drying	Fundamental for any professional role; influences the ability to effectively perform specialized tasks
Methodological Skill	Ability to apply appropriate techniques and methods	– Applying Scrum or Lean Six Sigma – Documenting and transferring insights into knowledge	Essential to promote innovation, strategic thinking, and investigation of deviations
Social Skill	Skills for effective interpersonal interactions	– Promoting collaboration – Mediating team conflicts – Inspiring leadership	Important in environments that rely on teamwork, dynamics, and culture
Self-Skill	Ability to manage oneself in various professional contexts	– Adapting to a fast-paced work environment – Working productively under pressure – Independent decision-making	Crucial in roles requiring a high degree of autonomy, such as leadership positions or independent work environments

Developing a Competency Model for Quality Gardeners

Building an effective competency model for quality professionals requires a systematic approach that aligns individual capabilities with organizational needs.

Step 1: Define Strategic Goals and Identify Key Roles

Begin by clearly articulating how quality contributes to organizational success. For a “living systems” approach to quality, goals might include:

Cultivating adaptive quality systems that evolve with the organization
Building resilience to regulatory changes and market disruptions
Fostering a culture where quality is everyone’s responsibility

From these goals, identify the critical roles needed to achieve them, such as:

Quality System Architects who design the overall framework
Process Gardeners who nurture specific quality processes
Cross-Pollination Specialists who transfer best practices across departments
System Immunologists who identify and respond to potential threats

Given your organization, you probably will have more boring titles than these. I certainly do, but it is still helpful to use the names when planning and imagining.

Step 2: Identify and Categorize Competencies

For each role, define the specific competencies needed across the four skill dimensions. For example:

Quality System Architect

Technical: Understanding of regulatory frameworks and system design principles
Methodological: Expertise in process mapping and system integration
Social: Ability to influence across the organization and align diverse stakeholders
Self: Strategic thinking and long-term vision implementation

Process Gardener

Technical: Deep knowledge of specific processes and measurement systems
Methodological: Proficiency in continuous improvement and problem-solving techniques
Social: Coaching skills and ability to build process ownership
Self: Patience and persistence in nurturing gradual improvements

Step 3: Create Behavioral Definitions

Develop clear behavioral indicators that demonstrate proficiency at different levels. For example, for the competency “Cultivating Quality Ecosystems”:

Foundational level: Understands basic principles of quality culture and can implement prescribed improvement tools

Intermediate level: Adapts quality approaches to fit specific team environments and facilitates process ownership among team members

Advanced level: Creates innovative approaches to quality improvement that harness the natural dynamics of the organization

Leadership level: Transforms organizational culture by embedding quality thinking into all business processes and decision-making structures

Step 4: Map Competencies to Roles and Development Paths

Create a comprehensive matrix that aligns competencies with roles and shows progression paths. This allows individuals to visualize their development journey and organizations to identify capability gaps.

For example:

Competency	Quality Specialist	Process Gardener	Quality System Architect
Statistical Analysis	Intermediate	Advanced	Intermediate
Process Improvement	Foundational	Advanced	Intermediate
Stakeholder Engagement	Foundational	Intermediate	Advanced
Systems Thinking	Foundational	Intermediate	Advanced

Building a Training Plan for Quality Gardeners

A well-designed training plan translates the competency model into actionable development activities for each individual.

Step 1: Job Description Analysis

Begin by analyzing job descriptions to identify the specific processes and roles each quality professional interacts with. For example, a Quality Control Manager might have responsibilities for:

Leading inspection readiness activities
Supporting regulatory site inspections
Participating in vendor management processes
Creating and reviewing quality agreements
Managing deviations, change controls, and CAPAs

Step 2: Role Identification

For each job responsibility, identify the specific roles within relevant processes:

Process	Role
Inspection Readiness	Lead
Regulatory Site Inspections	Support
Vendor Management	Participant
Quality Agreements	Author/Reviewer
Deviation/CAPA	Author/Reviewer/Approver
Change Control	Author/Reviewer/Approver

Step 3: Training Requirements Mapping

Working with process owners, determine the training requirements for each role. Consider creating modular curricula that build upon foundational skills:

Foundational Quality Curriculum: Regulatory basics, quality system overview, documentation standards

Technical Writing Curriculum: Document creation, effective review techniques, technical communication

Process-Specific Curricula: Tailored training for each process (e.g., change control, deviation management)

Step 4: Implementation and Evolution

Recognize that like the quality systems they support, training plans should evolve over time:

Update as job responsibilities change
Adapt as processes evolve
Incorporate feedback from practical application
Balance formal training with experiential learning opportunities

Cultivating Excellence Through Competency Development

Building a competency framework aligned with the “living systems” view of quality management transforms how organizations approach quality professional development. By nurturing technical, methodological, social, and self-skills in balance, organizations create quality professionals who act as true gardeners—professionals who cultivate environments where quality naturally flourishes rather than imposing it through rigid controls.

As quality systems continue to evolve, the most successful organizations will be those that invest in developing professionals who can adapt and thrive amid complexity. These “quality gardeners” will lead the way in creating systems that, like healthy ecosystems, become more resilient and vibrant over time.

Applying the Competency Model

For organizational leadership in quality functions, adopting a competency model is a transformative step toward building a resilient, adaptive, and high-performing team—one that nurtures quality systems as living, evolving ecosystems rather than static structures. The competency model provides a unified language and framework to define, develop, and measure the capabilities needed for success in this gardener paradigm.

The Four Dimensions of the Competency Model

Competency Model Dimension	Definition	Examples	Strategic Importance
Technical Competency	Specialized knowledge and practical abilities required for quality roles	– Understanding aseptic processing – Mastering root cause analysis – Operating quality management software	Fundamental for effective execution of specialized quality tasks and ensuring compliance
Methodological Competency	Ability to apply structured techniques, frameworks, and continuous improvement methods	– Applying Lean Six Sigma – Documenting and transferring process knowledge – Designing audit frameworks	Drives innovation, strategic problem-solving, and systematic improvement of quality processes
Social Competency	Skills for effective interpersonal interactions and collaboration	– Facilitating cross-functional teams – Mediating conflicts – Coaching and inspiring others	Essential for cultivating a culture of shared ownership and teamwork in quality initiatives
Self-Competency	Capacity to manage oneself, adapt, and demonstrate resilience in dynamic environments	– Adapting to change – Working under pressure – Exercising independent judgment	Crucial for autonomy, leadership, and thriving in evolving, complex quality environments

Leveraging the Competency Model Across Organizational Practices

To fully realize the gardener approach, integrate the competency model into every stage of the talent lifecycle:

Recruitment and Selection

Role Alignment: Use the competency model to define clear, role-specific requirements—ensuring candidates are evaluated for technical, methodological, social, and self-competencies, not just past experience.
Behavioral Interviewing: Structure interviews around observable behaviors and scenarios that reflect the gardener mindset (e.g., “Describe a time you nurtured a process improvement across teams”).

Rewards and Recognition

Competency-Based Rewards: Recognize and reward not only outcomes, but also the demonstration of key competencies—such as collaboration, adaptability, and continuous improvement behaviors.
Transparency: Use the competency model to provide clarity on what is valued and how employees can be recognized for growing as “quality gardeners.”

Performance Management

Objective Assessment: Anchor performance reviews in the competency model, focusing on both results and the behaviors/skills that produced them.
Feedback and Growth: Provide structured, actionable feedback linked to specific competencies, supporting a culture of continuous development and accountability.

Training and Development

Targeted Learning: Identify gaps at the individual and team level using the competency model, and develop training programs that address all four competency dimensions.
Behavioral Focus: Ensure training goes beyond knowledge transfer, emphasizing the practical application and demonstration of new competencies in real-world settings.

Career Development

Progression Pathways: Map career paths using the competency model, showing how employees can grow from foundational to advanced levels in each competency dimension.
Self-Assessment: Empower employees to self-assess against the model, identify growth areas, and set targeted development goals.

Succession Planning

Future-Ready Talent: Use the competency model to identify and develop high-potential employees who exhibit the gardener mindset and can step into critical roles.
Capability Mapping: Regularly assess organizational competency strengths and gaps to ensure a robust pipeline of future leaders aligned with the gardener philosophy.

Leadership Call to Action

For quality organizations moving to the gardener approach, the competency model is a strategic lever. By consistently applying the model across recruitment, recognition, performance, development, career progression, and succession, leadership ensures the entire organization is equipped to nurture adaptive, resilient, and high-performing quality systems.

This integrated approach creates clarity, alignment, and a shared vision for what excellence looks like in the gardener era. It enables quality professionals to thrive as cultivators of improvement, collaboration, and innovation—ensuring your quality function remains vital and future-ready.

Reflective Learning to Build Competent Teams

Organizational Competencies

Organizational competencies are the skills, abilities, and knowledge that allow an organization to be successful in achieving its goals. They form the foundation of an organization’s culture, values, and strategy.

Organizational competencies can be broadly divided into two main categories:

Technical Competencies
Non-Technical Competencies (also called General Competencies)

Technical Competencies

Technical competencies are specific skills and knowledge required to perform particular jobs or functions within an organization. They are directly related to the core business activities and technical aspects of the work. For technical competencies:

They cover various fields of expertise relevant to the specific work carried out in the organization
They are at the heart of what the organizational employees do
They allow an organization to produce products or services efficiently and effectively
They often require ongoing training and reinforcement to stay current

Non-Technical Competencies

Non-technical competencies, also known as general competencies or soft skills, are broader skills and attributes that are important across various roles and functions. They include:

These competencies are crucial for effective interaction, collaboration, and overall organizational success.

Organizational Competencies for Validation (an example)

For an organization focusing on validation the following competencies would be particularly relevant:

Technical Competencies

Skill Area	Key Aspects	Proficiency Levels
Skill Area	Key Aspects	Beginner	Intermediate	Advanced	Expert
General CQV Principles	Modern process validation and guidance Validation design and how to reduce variability	Able to review a basic protocol Able to review/approve Validation document deliverables. Understands the importance of a well-defined URS.	Able to be QEV lead in a small project Able to answer questions and guide others in QEV Participates in process improvement Able to review and approve RTM/SRs	Able to be QEV lead in a large project project Trains and mentors others in QEV Leads process improvement initiatives Able to provide Quality oversight on the creation of Validation Plans for complex systems and/or projects	Sets overall CQV strategy Recognized as an expert outside of JEB
Facilities and Utilities	Oversee Facilities, HVAC and Controlled Environments Pharma Water and WFI Pure Steam, Compressed Air, Medical Gases	Understands the principles and GMP requirements	Applies the principles, activities, and deliverables that constitute an efficient and acceptable approach to demonstrating facility fitness-for-use/qualification	Guide the Design to Qualification Process for new facilities/utilities or the expansion of existing facilities/utilities	Able to establish best practices
Systems and Equipment	Equipment, including Lab equipment	Understands the principles and GMP requirements	Principles, activities, and deliverables that constitute an efficient and acceptable approach to demonstrating equipment fitness-for-use/qualification	Able to provide overall strategy for large projects Able to be QEV lead on complex systems and equipment.	Able to establish best practices
Computer Systems and Data Integrity	Computer lifecycle, including validation	Understands the principles and GMP requirements	Able to review CSV documents Apply GAMP5 risk based approach Day-to-day quality oversight	Able to provide overall strategy for a risk based GAMP5 approach to computer system quality	Able to establish best practices
Asset Lifecycle	Quality oversight and decision making in the lifecycle asset lifecycle: Plan, acquire, use, maintain, and dispose of assets	Can use CMMS to look up Calibrations, Cal schedules and PM schedules	Quality oversight of asset lifecycle decisions Able to provide oversight on Cal/PM frequency Able to assess impact to validated state for corrective WO’s.	Able to establish asset lifecycle for new equipment classes Establish risk-based PM for new asset classes verification	Establish asset lifecycle approach Serves as the organization’s authority on GMP requirements related to asset management in biotech facilities Implements sophisticated risk assessment methodologies tailored to biotech asset management challenges
Quality Systems	SOP/WI and other GxP Documents Deviation Change Control	Able to use the eQMS	Deviation reviewer (minor/major) Change Control approver Document author/approver	Deviation reviewer (critical) Manage umbrella/Parent changes	Able to set strategic direction
Cleaning, Sanitization and Sterilization Validation	Evaluate and execute cleaning practices, limit calculations, scientific rationales, and validation documents Manage the challenges of multi-product facilities in the establishment of limits, determination of validation strategies, and maintaining the validated state	Differentiate the requirements for cleaning and sterilization validation when using manual, semi-automatic, and automatic cleaning technologies Review protocols	Identify and characterize potential residues including product, processing aids, cleaning agents, and adventitious agents Understand Sterilization principles and requirements Create, review and approve scientifically sound rationales, validation protocols, and reports	Manage and remediate the pitfalls inherent in cleaning after the production of biopharmaceutical and pharmaceutical products	Define cleaning/sterilization validation strategy Implements a lifecycle approach to validation, ensuring continued process verification Implements a lifecycle approach to validation, ensuring continued process verification
Quality Risk Management	Apply QRM principles according to Q9	Understands basic risk assessment principles Can identify potential hazards and risks Familiar with risk matrices and scoring methods Participate in a risk assessment	Conducts thorough risk assessments using established methodologies Analyzes risks quantitatively and qualitatively Prioritizes risks based on likelihood and impact Determine appropriate tools Establish risk-based decision-making tools	Leads complex risk assessments across multiple areas Develops new risk assessment methodologies Provides expert guidance on risk analysis techniques	Serves as the organization’s authority on regulatory requirements and expectations related to quality risk management Builds a proactive risk culture across the organization, fostering risk awareness at all levels
Process Validation	Demonstrating that the manufacturing process can consistently produce a product that meets predetermined specifications and quality attributes.	Understanding of GMP principles and regulatory requirements Basic understanding of GMP principles and regulatory requirements	Can independently write, approve and execute validation protocols for routine processes Ability to develop validation master plans and protocols Understanding of critical process parameters (CPPs) and critical quality attributes (CQAs)	Expertise in designing and implementing complex validation strategies Ability to troubleshoot and resolve validation issues Deep understanding of regulatory expectations and industry best practices	Leads cross-functional validation teams for high-impact projects Develops innovative validation approaches for novel bioprocesses Serves as an organizational authority on validation matters and regulatory interactions

Non-Technical Competencies:

Critical thinking and problem-solving skills
Attention to detail
Project management abilities
Effective communication (both written and verbal)
Teamwork and collaboration skills
Adaptability to changing regulatory environments
Ethical decision-making
Continuous learning and improvement mindset
Leadership and mentoring capabilities
Time management and organizational skills

Apply Reflective Learning for Continuous Learning

Reflective learning is a powerful tool that organizations can leverage to build competency and drive continuous improvement. At its core, this approach involves actively analyzing and evaluating experiences and learning processes to enhance understanding and performance across all levels of the organization.

The process of reflective learning begins with individuals and teams taking the time to step back and critically examine their actions, decisions, and outcomes. This introspection allows them to identify what worked well, what didn’t, and why. By doing so, they can uncover valuable insights that might otherwise go unnoticed in the day-to-day rush of business activities.

One of the key benefits of reflective learning is its ability to transform tacit knowledge into explicit knowledge. Tacit knowledge is the unspoken, intuitive understanding that individuals develop through experience. By reflecting on and articulating these insights, organizations can capture and share this valuable wisdom, making it accessible to others and fostering a culture of collective learning.

To implement reflective learning effectively, organizations should create structured opportunities for reflection. This might include regular debriefing sessions after projects, dedicated time for personal reflection, or the use of learning journals. Additionally, leaders should model reflective practices and encourage open and honest discussions about both successes and failures.

It’s important to note that reflective learning is not just about looking back; it’s also about looking forward. The insights gained through reflection should be used to inform future actions and strategies. This forward-thinking approach helps organizations to be more adaptable and responsive to changing circumstances, ultimately leading to improved performance and innovation.

By embracing reflective learning as a core organizational practice, companies can create a dynamic environment where continuous learning and improvement become ingrained in the culture. This not only enhances individual and team performance but also contributes to the overall resilience and competitiveness of the organization in an ever-changing business landscape.

Implement Regular After-Action Reviews

After-action reviews (AARs) or Lessons Learned are critical to provide a structured way for teams to reflect on projects, initiatives, or events. To implement effective AARs:

Schedule them immediately after key milestones or project completions
Focus on what was planned, what actually happened, why there were differences, and what can be learned
Encourage open and honest discussion without blame
Document key insights and action items

Create a Supportive Environment for Reflection

Foster a culture that values and encourages reflection:

Provide dedicated time and space for individual and group reflection
Model reflective practices at the leadership level
Recognize and reward insights gained through reflection

By systematically implementing these practices, organizations can build a strong competency in reflective learning, leading to improved decision-making, innovation, and overall performance. Utilizing a model always helps.

Kolb’s Reflective Model

Kolb’s reflective model, also known as Kolb’s experiential learning cycle, is a widely used framework for understanding how people learn from experience. The model consists of four stages that form a continuous cycle of learning:

The Four Stages of Kolb’s Reflective Model

Concrete Experience: This is the stage where the learner actively experiences an activity or situation. It involves direct, hands-on involvement in a new experience or a reinterpretation of an existing experience.
Reflective Observation: In this stage, the learner reflects on and reviews the experience. They think about what happened, considering their feelings and the links to their existing knowledge and skills.
Abstract Conceptualization: Here, the learner forms new ideas or modifies existing abstract concepts based on their reflections. This stage involves analyzing the experience and drawing conclusions about what was learned.
Active Experimentation: In the final stage, the learner applies their new knowledge and tests it in new situations. This involves planning how to put the new learning into practice and experimenting with new approaches.

Applying Kolb’s Model

Kolb’s reflective model should be utilized as part of knowledge management:

Create Opportunities for Concrete Experiences: Provide employees with hands-on learning experiences, such as job rotations, simulations, or real-world projects.
Encourage Reflection: Set up regular reflection sessions or debriefings after significant experiences. Encourage employees to keep learning journals or participate in group discussions to share their observations.
Facilitate Conceptualization: Provide resources and support for employees to analyze their experiences and form new concepts. This could involve training sessions, mentoring programs, or access to relevant literature and research.
Support Active Experimentation: Create a safe environment for employees to apply their new knowledge and skills. Encourage innovation and provide opportunities for employees to test new ideas in their work.
Integrate the Model into Learning Programs: Design training and development programs that incorporate all four stages of Kolb’s cycle, ensuring a comprehensive learning experience.
Personalize Learning: Recognize that individuals may have preferences for different stages of the cycle. Offer diverse learning opportunities to cater to various learning styles.
Measure and Iterate: Regularly assess the effectiveness of knowledge management initiatives based on Kolb’s model. Use feedback and results to continuously improve the learning process.

By incorporating Kolb’s reflective model into knowledge management practices, we can create a more holistic and effective approach to learning and development. This can lead to improved knowledge retention, better application of learning to real-world situations, and a more adaptable and skilled workforce.

Other Experiential Learning Models

Model	Key Proponents	Main Components	Unique Features
Experiential Learning Theory (ELT)	David Kolb	1. Concrete Experience 2. Reflective Observation 3. Abstract Conceptualization 4. Active Experimentation	– Cyclical process – Incorporates learning styles (Accommodator, Diverger, Assimilator, Converger)
Reflective Cycle	Graham Gibbs	1. Description 2. Feelings 3. Evaluation 4. Analysis 5. Conclusion 6. Action Plan	– Structured approach to reflection – Emphasizes emotional aspects
Reflection-in-Action and Reflection-on-Action	Donald Schön	1. Reflection-in-action 2. Reflection-on-action	– Focuses on professional practice – Emphasizes real-time reflection
Single and Double Loop Learning	Chris Argyris, Donald Schön	1. Single-loop learning 2. Double-loop learning	– Distinguishes between adjusting actions and questioning assumptions – Applicable to organizational learning
Jarvis’s Model	Peter Jarvis	Multiple pathways including: 1. Non-learning 2. Non-reflective learning 3. Reflective learning	– Expands on Kolb’s work – Recognizes various responses to potential learning situations
Backward Design	Grant Wiggins, Jay McTighe	1. Identify desired results 2. Determine acceptable evidence 3. Plan learning experiences and instruction	– Starts with learning outcomes – Focuses on designing effective learning experiences

Applying the Experiential Learning Model to Validation Competencies

To apply Kolb’s experiential learning model to building an organization’s competency for validation, we can structure the process as follows:

Concrete Experience

Have employees participate in actual validation activities or simulations
Provide hands-on training sessions on validation techniques and tools
Assign validation tasks to teams in real projects

Reflective Observation

Conduct debriefing sessions after validation activities
Encourage employees to keep validation journals or logs
Facilitate group discussions to share experiences and observations
Review validation results and outcomes as a team

Abstract Conceptualization

Offer formal training on validation principles, methodologies, and best practices
Encourage employees to develop validation frameworks or models based on their experiences
Analyze validation case studies from other organizations or industries
Create validation guidelines and standard operating procedures

Active Experimentation

Implement new validation approaches in upcoming projects
Encourage employees to propose and test innovative validation methods
Set up pilot programs to trial new validation tools or techniques
Assign employees to different types of validation projects to broaden their skills

To make this process continuous and effective:

Create a validation competency framework with clear learning objectives and skill levels
Develop a mentoring program where experienced team members guide less experienced colleagues
Establish regular knowledge-sharing sessions focused on validation topics
Implement a system for capturing and disseminating lessons learned from validation activities
Use technology platforms to support collaborative learning and information sharing about validation
Regularly assess and update the organization’s validation processes based on learning outcomes
Encourage cross-functional teams to work on validation projects to broaden perspectives
Partner with external experts or organizations to bring in fresh insights and best practices
Recognize and reward employees who demonstrate growth in validation competencies
Integrate validation competency development into performance reviews and career progression paths

By systematically applying Kolb’s model, we can create a robust learning environment that continuously improves our validation capabilities. This approach ensures that employees not only gain theoretical knowledge but also practical experience, leading to a more competent and adaptable workforce.

Where used	Meaning
Physics	The property of a material to absorb energy when deformed and not fracture nor break; in other words, the material’s elasticity.
Ecology	The capacity of an ecosystem to absorb and respond to disturbances without permanent damage to the relationships between species.
Psychology	An individual’s coping mechanisms and strategies.
Organizational and Management studies	The ability to maintain an acceptable level of service in the face of periodic or catastrophic systemic and singular faults and disruptions (e.g. natural disasters, cyber or terrorist attacks, supply chain disturbances).