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:

1. Technical Competencies
2. 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:

• Communication skills
• Leadership
• Teamwork
• Problem-solving
• Adaptability
• Innovation
• Strategic thinking

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
		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:

1. Critical thinking and problem-solving skills
2. Attention to detail
3. Project management abilities
4. Effective communication (both written and verbal)
5. Teamwork and collaboration skills
6. Adaptability to changing regulatory environments
7. Ethical decision-making
8. Continuous learning and improvement mindset
9. Leadership and mentoring capabilities
10. 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

1. 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.
2. 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.
3. 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.
4. 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:

1. Create Opportunities for Concrete Experiences: Provide employees with hands-on learning experiences, such as job rotations, simulations, or real-world projects.
2. 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.
3. 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.
4. 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.
5. 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.
6. Personalize Learning: Recognize that individuals may have preferences for different stages of the cycle. Offer diverse learning opportunities to cater to various learning styles.
7. 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

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:

1. Create a validation competency framework with clear learning objectives and skill levels
2. Develop a mentoring program where experienced team members guide less experienced colleagues
3. Establish regular knowledge-sharing sessions focused on validation topics
4. Implement a system for capturing and disseminating lessons learned from validation activities
5. Use technology platforms to support collaborative learning and information sharing about validation
6. Regularly assess and update the organization’s validation processes based on learning outcomes
7. Encourage cross-functional teams to work on validation projects to broaden perspectives
8. Partner with external experts or organizations to bring in fresh insights and best practices
9. Recognize and reward employees who demonstrate growth in validation competencies
10. 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.