Fostering Critical Thinking

As a leader, fostering critical thinking in my team and beyond is a core part of my job. Fostering critical thinking means an approach that encourages open-mindedness, curiosity, and structured problem-solving.

Encourage Questioning and Healthy Debate

It is essential to create an environment where team members feel comfortable questioning assumptions and engaging in constructive debates. Encourage them to ask “why” and explore different perspectives. This open dialogue promotes deeper thinking and prevents groupthink.

Foster a Culture of Curiosity

Inspire your team to ask questions and seek deeper understanding. Role model this behavior by starting meetings with thought-provoking “what if” scenarios or sharing your own curiosities. Celebrate curiosity and reward those who think outside the box.

Assign Stretch Assignments

Provide your team with challenging tasks that push them beyond their comfort zones. These stretch assignments force them to think critically, analyze information from multiple angles, and develop innovative solutions.

Promote Diverse Perspectives

Encourage diversity of thought within your team. Diverse backgrounds, experiences, and viewpoints can challenge assumptions and biases, leading to a more comprehensive understanding and better decision-making.

Engage in Collaborative Problem-Solving

Involve your team in decision-making processes and problem-solving exercises. Techniques like role reversal debates, where team members argue a point they disagree with, can help them understand different perspectives and refine their argumentative skills.

Provide Training and Resources

Offer training sessions on critical thinking techniques, such as SWOT analysis, root cause analysis, and logical fallacies. Equip your team with the tools and frameworks they need to think critically.

Lead by Example

As a leader, model critical thinking behaviors. Discuss your thought processes openly, question your assumptions, and show the value of critical evaluation in real-time decision-making. Your team will be more likely to emulate these habits.

Encourage Continuous Learning

Recommend learning resources, such as courses, articles, and books from diverse fields. Continuous learning can broaden perspectives and foster multifaceted thinking.

Embrace Feedback and Mistakes

Establish feedback loops within the team and create a safe environment where mistakes are treated as learning opportunities. Receiving and giving feedback helps refine understanding and overcome biases.

Implement Role-Playing Scenarios

Use role-playing scenarios to simulate real-world challenges. This helps team members practice critical thinking in a controlled environment, enhancing their ability to apply these skills in actual situations.

Build Into the Team Charter

Building these expectations into the team charter holds you and your team accountable.

Value: Regulatory Intelligence

Definition: Stay current on industry regulations and guidances.

Desired Behaviors:

I will dedicate time to reading industry-related guidance and regulation publications related to my job.
I will share publications that I find interesting or applicable to my job with the team
I will present to the team on at least one topic per year to share learnings with the team (or wider organization)

Value: Learning Culture

Definition: Share lessons learned from projects so the team can grow together and remain aligned. Engage in knowledge-sharing sessions.

Desired Behaviors:

I will share lessons learned from each project with the wider team via the team channel and/or weekly team meeting.
I will encourage team members to openly share their experiences, successes, and challenges without fear of judgement.
I will update RAID log with decisions made by the team.
I will identify possible process improvements and update the process improvement tracker.

Value: Team Collaboration

Definition: Willingness to help teammates when they reach out for input/help

Desired Behaviors:

I will be supportive of my teammate’s requests for assistance
I will engage and offer my SME advice when asked or help identify another SME to assist
I will not ignore requests for input/help
I will contribute to an environment where teammates can request help

Where I am at

I recently joined Just Evotec Biologics as the Senior Director of Global Quality Engineering and Validation. For a variety of reasons (just look at my past company on my LinkedIn bio and search the news to find one) it was a good time to move. I had decided that I wanted a position that was tied to an innovative manufacturing company and was deep in domain expertise. The combination of Just Evotec Biologics innovative technology aims and the ability to deep dive into one of my favorite topics was just too much to resist. Add to it the opportunity to work with a leader I deeply respected again and well, here I am. And feeling very good about it.

When I first started I met with the team and laid out my 30-60-90 day goals.

As well as talking a little about how I operate.

A big chunk of my time has been getting the lay-of-the-land institutionally. Setting some standards, doing gap assessments, figuring out what-is-what, and getting to know all my partners and stakeholders. For reasons of confidentiality, this post won’t be going deep on that.

What I do want to talk about is our team values and ways of working. I’ve been focused heavily on three areas with the team:

Team Values
Team Decision Making
Team Competencies

Team Values

We did a few workshops where we identified a set of values:

Leader to Team: How I expect the team to perform
Team to Leader: How the Team expects me to perform
Team to Team: How we expect each other to perform

This exercise really helped me understand what was going on within the team and through it I really started to understand some priorities.

For each of these, we created a Value Statement. Here are some examples.

Value: United Front

Definition: Decisions are made and recorded honestly and transparently. Employees understand decisions and how to execute them. The entire team represents the decisions made, and the decision-making process with one voice.

Desired Behaviors:

I hold myself accountable for representing the decisions made by the team.
I work to anticipate and fend off the possibility of failures occurring.
I engage with decision making and respect the decisions that result.

Value: Open to Change

Definition: Willingness to listen to the team. Actively looking for feedback and input from the team before making decisions that impact the team. Open to changing established ways and revisiting previously made decisions.

Desired Behaviors:

I will be transparent with decision-making.
I will create an environment where new ideas are welcome and challenging ideas are encouraged.
I will include the team in decision-making where applicable.
I will actively seek out individual and group feedback to enable continuous improvements.

Value: Learning Culture

Definition: Share lessons learned from projects so team can grow together and remain aligned. Engage in knowledge-sharing sessions.

Desired Behaviors:

I will share lessons learned from each project with the wider QEV team via teams channel &/or weekly team meetings.
I will encourage team members to openly share their experiences, successes, and challenges without fear of judgement.
I will update RAID log with decisions made by the team.
I will identify possible process improvements and update the process improvement tracker

Team Decision Making

Currently working with the team to define decision-making, introducing the RAPID model and working on a matrix of decisions.

Team Competencies

Starting with technical skills we are defining our core competencies. Next, we will tackle, with the larger quality organization, the soft skill side of the equation. This is definitely a work in progress.

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	� Establish asset lifecycle approach
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 to meet GMP requirements
Quality Risk Management	� Apply QRM principles according to Q9		� Participate in a risk assessment	� Determine appropriate tools � Establish risk-based decision-making tools	� Set risk-based approaches	� Define risk management program for CQV activities

I’d love feedback on this.

My Overall Philosophy

I’ve been focusing on five key tasks as a leader in this organization:

How I build and gain agreement
Grow the Team
Results and Learning
Deliberate Presence
Prioritizing the Right Relationship

Still a lot to do but I am having a blast.

The Team/Workgroup Charter, and When to Revisit

Teams and Work-Groups need ground rules, they should have a charter, which includes a nice vision of how the team sees itself.

Let’s be honest, we do not spend enough time building and maintaining these charters. If you are like me you tend to dive right in, and that will always cause some problems. Luckily, it is never too late to take a step back and do the work.

Start by answering these eight questions about the team and its place in the organization.

Consistency with organizational objectives: The team vision should be aligned with and derive from the organization’s overall purpose and strategy. Teams are sub-elements in a wider organization structure and their success will be judged on the extent to which they make valuable contributions to the overall purpose of the organization. In some circumstances, a team may decide that it is important for its own values, purposes, and orientations to act as a minority group that aims to bring about change in organization objectives – perhaps like a red team.
Receiver needs: How a team focuses on providing excellence in service to their customers, whether internal or external.
Quality of work: A major emphasis within organizations is the quality of work. The relationship between quality and other functions like efficiency is important.
Value to the wider organization: Understanding the importance of the team just not for the wider organization but beyond, leads to team cohesion and greater team effectiveness. Team members need a clear perception of the purposes of their work.
Team-climate relationships: Team climate refers to aspects such as warmth, humor, amount of conflict, mutual support, sharing, backbiting, emphasis on status, participation, information sharing, level of criticism of each other’s work, and support for new ideas.
Growth and well-being of team members: Growth, skill development and challenges are central elements of work-life, and teams can be a major source of support. Teams provide opportunities for skill sharing and support for new training. Teams need to be concerned for the well-being of their members, including things like burnout.
Relationships with other teams and departments in the organization: Teams rarely operate in isolation. They interact with other team and departments within the organization. Teams must be committed to working effectively and supporting other teams. Avoid silo thinking.

From there you can then generate the 10 aspects of the charter:

Team Ground Rules: What positive behaviors/values will the team seek to embrace and exemplify?
Trust Damagers and Destroyers: What negative behaviors would damage/destroy trust in the team and how will the team avoid/deal with these?
Conflicts of Interest: Are there any possible conflict of interest scenarios and, if so, how should they be handled?
Team Boundaries: What are the boundaries of the team and the different types of team participation?
Information Sharing: Where will there be transparency of information sharing and where will there be privacy and restricted sharing within the team?
Issue and Conflict Resolution: How will issues and conflicts be resolved?
Decision Making Practices: How will decisions be made?
Meetings: Type, frequency, purpose, attendees and channels
Induction, Mentoring, Buddying: How (and if) will new members be brought into the team?
Communications: What tools will be used for communications and what are the agreed to “Reply-by” times

Do not short communication

How much time do you spend communicating every day? Whether this is through phone calls, IM, texts, email, written reports, face-to-face conversations, or meetings, many of us spend a large proportion of our day dealing with messages that demand our attention.

Be deliberate in how we manage these interactions so that people communicate efficiently and effectively. Outline preferred methods of communication, how to use different channels effectively, and what people want to achieve. By improving communication you can drive for effective meetings, reduce the volume of emails, ensure that exchanges are professional, and free up time for high-value tasks.

Include the following in your communication section:

When people need to reply to emails and when they don’t.
When people should “Reply All” to emails and when they should avoid it.
How to organize regular team meetings, who should attend, whether people will “dial in” remotely, what to include in the minutes, who will circulate them, and so on.
How your team communicates with customers internal and external.
How team members interact on internal social media (chat, slack, etc).
When making a video or audio call is appropriate.
How people engage with others face-to-face.

Signs of Team/Work-Group Misalignment

There are some behaviors to look out for, when you see them, it’s time to return to the charter, and improve.

Vague Feelings of Fear. You know what the team is supposed to deliver on, but you don’t know how exactly you’re supposed to work with anything in your power or control to “move the needle.”

Ivory Tower Syndrome. Things aren’t clear or different people have different expectations for a project or initiative. No one is really able to clarify.

Surprises. Someone committed you to a task, but you weren’t part of that decision.

Emergencies. How often are you called on to respond to something that’s absolutely needed by close of business today? How often are you expected to drop everything and take care of it? How often do you have to work nights and weekends to make sure you don’t fall behind?

Cut Off at the Pass: Someone else is doing the same work unaware to all.

Not Writing Things Down. You have to make sure everyone is literally on the same page, seeing the world in a similar enough way to know they are pursuing the same goals and objectives. If you don’t write things down, you may be at the mercy of cognitive biases later. How do you know that your goals and objectives are aligned with your overall company strategy? Can you review written minutes after key meetings? Are your team’s strategic initiatives written and agreed to by decision-makers? Do you implement project charters that all stakeholders have to sign off on before work can commence? What practices do you use to get everyone on the same page?

Building the Risk Team

Good risk assessments are a team effort. If done right this is a key way to reduce subjectivity and it recognizes that none of us know everything.

An effective risk team:

Has expertise in the subject
Knows how to drive decision making
Includes representatives of all relevant stakeholders
Is cross-functional and multidisciplinary
Allows appropriate and applicable empowerment

One of the core jobs of a process owner in risk assessment is assembling this team and ensuring they have the space to do their job. They are often called the champion or sponsor for good reason.

It is important to keep in mind that membership of this team will change, gaining and losing members and bringing on people for specific subsections, depending on the scale and scope of the risk assessment.

The more complex the scope and the more involved the assessment tool, the more important it is to have a facilitator to drive the process. This allows someone to focus on the process of the risk assessment, and the reduction of subjectivity.

Teams Need Vision Too

Teams exist to execute to organization objectives. In order to meet these objectives, a team needs a vision of itself. There are eight major elements to a team’s vision:

Consistency with organizational objectives: The team vision should be aligned with and derive from the organization’s overall purpose and strategy. Teams are sub-elements in a wider organization structure and their success will be judged on the extent to which they make valuable contributions to the overall purpose of the organization. In some circumstances a team may decide that it is important for its own values, purposes and orientations to act as a minority group which aims to bring about change in organization objectives – perhaps like a red team.
Receiver needs: Teams focus on providing excellence in service to its customers, whether internal or external.
Quality of work: A major emphasis within organizations is the quality of work. The relationship between quality and other functions like efficiency is important.
Value to the wider organization: Understanding the importance of the team just not for the wider organization but beyond, leads to team cohesion and greater team effectiveness. Team members need a clear perception of the purposes of their work.
Team-climate relationships: Team climate refers to aspects such as the warmth, humor, amount of conflict, mutual support, sharing, backbiting, emphasis on status, participation, information sharing, level of criticism of each other’s work and support for new ideas.
Growth and well-being of team members: Growth, skill development and challenge are central elements of work life and teams can be a major source of support. Teams provide opportunities for skill sharing and support for new training. Teams need to be concerned for the well-being of its members, including things like burnout.
Relationships with other teams and departments in the organization: Teams rarely operate in isolation. They interact with other team and departments within the organization. Teams must be committed to working effectively and supporting other teams. Avoid silo thinking.