Critical Thinking: Lessons from Leonardo da Vinci

Introduction

What is critical thinking?

Leonardo da Vinci

Lessons from Leonardo

Critical thinking in life sciences

Challenges

Critical thinking tools

Actionable insights

How do life sciences organizations benefit

Takeaways

Introduction

Leonardo da Vinci was a master of observation, experimentation, and invention—qualities that have made him a symbol of critical thinking. His ability to analyze, question, and redesign processes mirrors the critical and analytical thinking needed in today’s life sciences. For Quality Assurance (QA) professionals, critical thinking is vital in meeting the demands of standards like Good Automated Manufacturing Practice (GAMP 5) and ensuring robust process validation and a robust computerized system, including Computer System Validation (CSV) and Computer Software Assurance (CSA).

In the life sciences, critical thinking enables informed decisions and risk-based judgment on where and how to apply quality and compliance activities for computerized systems across the entire lifecycle - from concept to retirement. As described by the Regulatory Affairs Professionals Society (RAPS), regulatory intelligence plays a key role in this, where professionals must track current regulations and anticipate changes in regulatory environments and their potential impacts on processes. This ability to foresee and adapt to changes is a core component of critical thinking in quality management.

This article will explore how da Vinci’s process-oriented critical thinking approach can be applied to GAMP 5, process validation, and decision-making in life sciences.

What is critical thinking?

Critical thinking in life sciences and quality assurance is an iterative process of systematically analyzing and evaluating information, processes, and assumptions. It involves questioning established practices, considering multiple perspectives, and applying risk-based approaches to make well-informed, evidence-based decisions that ensure patient safety, product quality, and data integrity while maximizing efficiency and regulatory compliance.

As The Foundation for Critical Thinking highlights, this process involves interpreting, analyzing, evaluating, and explaining evidence and concepts clearly and accurately. These skills are vital in the life sciences industry, where regulatory demands such as those from GAMP 5 and FDA guidelines—like 21 CFR Part 11 (Electronic Records; Electronic Signatures), 21 CFR Part 820 (Quality System Regulation for medical devices), and 21 CFR Part 211 (Current Good Manufacturing Practice for Finished Pharmaceuticals)—require a high level of critical thinking to ensure safety, quality, and compliance.

In the context of QA, critical thinking enables informed decision-making on how to best implement and scale quality and compliance measures for computerized systems. It involves a thorough understanding of the business process and a detailed analysis of potential risks that could affect patient safety, product quality, and data integrity. By applying this critical approach, QA managers can ensure compliance efforts are strategically focused and multi-layered regarding quality, ensuring regulatory adherence and systems reliability within life sciences environments.

Leonardo da Vinci: A pioneer of critical thinking

Leonardo da Vinci (1452–1519) was an Italian polymath whose contributions spanned art, science, and engineering, making him one of the most influential figures in history. Beyond his artistic masterpieces like the Mona Lisa and The Last Supper, da Vinci’s scientific studies in anatomy, geology, and hydrodynamics were groundbreaking. His detailed anatomical drawings, based on dissections, advanced medical understanding, while his observations of water movement and erosion laid early foundations for geology.

"I have been impressed with the urgency of doing. Knowing is not enough; we must apply. Being willing is not enough; we must do."

Da Vinci’s call to action resonates with the continuous improvement mindset in QA, where identifying issues isn’t sufficient. Teams must take action to improve systems and processes.

Lessons from Leonardo

The intersection of art, science, and critical thought

In engineering, da Vinci designed numerous machines, including early concepts for helicopters, flying machines, and tanks, many of which were far ahead of their time. His designs showcased his ability to merge creative thinking with scientific principles, influencing future innovations like aeronautics and robotics. His multidisciplinary approach and critical thinking serve as enduring inspiration for modern fields, including life sciences.

Rethinking processes and continuous improvement 

Leonardo frequently questioned established norms and methods, from painting to engineering. His relentless curiosity drove him to challenge accepted truths, making him ask "why" and "how" in ways others didn’t. For example, his dissection of human cadavers led to detailed anatomical drawings that corrected several inaccuracies in the medical knowledge of his time. 

Similarly, QA managers must consistently rethink and refine processes, questioning existing procedures to identify inefficiencies or areas for continuous improvement. Whether it's improving quality workflows, optimizing risk management strategies, or enhancing regulatory compliance, the ability to challenge the status quo is vital in maintaining high standards in life sciences. Just like Leonardo, QA managers must be innovative problem-solvers who drive progress by continuously rethinking how things are done.

Curiosity, attention to detail, and documentation

One of da Vinci's greatest strengths was his meticulous attention to detail. His sketchbooks, filled with diagrams, engineering designs, and anatomical studies, reveal his commitment to documentation—just as detailed record-keeping is critical in life sciences. His obsessive documentation allowed him to refine his ideas over time, such as how QA managers must maintain thorough records to ensure compliance, traceability, and accuracy in life sciences. Just as da Vinci's curiosity drove him to explore and perfect his work, QA managers must continuously ask questions, identify potential risks, and apply a keen eye to even the smallest details to ensure product quality and regulatory validation.

Critical thinking in life sciences

GAMP 5 compliance

Da Vinci’s systematic approach can be applied to today's Good Automated Manufacturing Practice (GAMP 5) compliance. Just as he used observation and analysis to create lasting breakthroughs, QA professionals use critical thinking to ensure their validation processes meet regulatory standards. Whether it’s CSV, CSA, or risk-based assessments under GAMP 5, rethinking and refining processes is essential to ensuring compliance in an ever-changing regulatory landscape. For example, risk-based thinking—central to GAMP 5—requires QA professionals to constantly assess which aspects of a system pose the highest risks and to focus validation efforts on those critical areas.

GAMP 5 and critical thinking

Critical thinking is a fundamental principle guiding decision-making in GAMP 5. Here’s how critical thinking is integrated into GAMP 5.

Risk-based decisions

Critical thinking is key in assessing and mitigating risks. QA professionals are encouraged to move away from rigid, prescriptive approaches and instead use judgment to evaluate the risks associated with each system or process. Critical thinking ensures that risks are prioritized based on their potential impact, allowing teams to focus resources effectively.

Flexibility in validation

GAMP 5 advocates for flexibility in validation processes rather than applying a one-size-fits-all approach. QA teams must use critical thinking to assess what level of validation is appropriate for each system based on its complexity and the associated risks.

Problem-solving

GAMP 5 encourages QA professionals to use critical thinking to solve problems that arise during the system lifecycle. This means going beyond standard procedures and applying logical analysis to resolve issues and improve processes.

Continuous improvement

Critical thinking is essential for fostering a culture of continuous improvement. GAMP 5 encourages teams to continually assess and refine validation processes to improve efficiency and ensure ongoing compliance.

Focus on patient safety and data integrity

Critical thinking ensures that all decisions, from initial system design to decommissioning, prioritize patient safety and data integrity. By critically evaluating each decision point, QA professionals can ensure that the systems they validate meet the highest quality and compliance standards.

GAMP 5 integrates critical thinking by encouraging life sciences professionals to use a flexible, risk-based approach that tailors validation efforts to the specific risks associated with computerized systems. By fostering a mindset of critical analysis, teams can improve compliance, focus on what matters most, and drive continuous improvement.

Data-driven decision-making

The International Society for Pharmaceutical Engineering (ISPE) emphasizes that applying critical thinking to testing practices can lead to more effective outcomes, especially in CSA. QA teams can uncover real-world issues more effectively by incorporating scripted and unscripted testing techniques like exploratory, ad-hoc, day-in-the-life, and error-guessing methods. This focus on targeted, data-driven testing allows teams to optimize validation efforts.

Critical thinking for computerized systems

Critical thinking for computerized systems is demonstrated through a proactive, risk-based approach that aligns with the system's intended use and considers the multiple assurance layers within the broader business process. These layers include technical, procedural, and behavioral controls that span the entire process, helping to assess the risks associated with the computerized system. The assurance may come from upstream and downstream activities within the business process, including supplier interactions.

Business process mapping and data flow diagrams are valuable tools for identifying and understanding potential risks to patient safety, product quality, and data integrity, allowing organizations to determine where assurance is most needed.

Critical thinking through the lifecycle

Critical thinking is not a one-time activity and should be applied throughout the computerized system life cycle. As such, critical thinking should become a habitual mindset based on an intellectual commitment to continual improvement.

Challenges in applying critical thinking in life sciences

Critical thinking tools within key methodologies for life sciences

Critical thinking tools are vital in enhancing methodologies such as Change Management, Continuous Monitoring, and Risk Assessment in life sciences QA. These tools enable QA teams to evaluate risks, make evidence-based decisions, and apply structured thinking to ensure compliance and efficiency within complex processes.

Essential tools like Root Cause Analysis (RCA), Risk-Based Thinking (RBT), and Failure Modes and Effects Analysis (FMEA) support these methodologies by identifying inefficiencies, assessing risks, and guiding corrective actions. By integrating critical thinking into processes like real-time risk monitoring and post-change evaluation, QA teams can consistently maintain quality and compliance throughout the system lifecycle.

Here is a summary of the critical thinking tools that can help optimize QA processes and improve decision-making efficiency within life sciences organizations.

1. Plan-Do-Check-Act (PDCA) Cycle

Overview

PDCA, or the Deming Cycle, is a four-step iterative method for continuous improvement. It promotes critical thinking by encouraging constant evaluation and refinement of processes.

Why it’s widely used

PDCA is one of the most recognized methodologies for continuous improvement in regulated industries like life sciences. It is particularly effective in validation processes, ensuring that teams continuously monitor, refine, and optimize systems to maintain compliance with evolving standards like GAMP 5 and FDA regulations.

Application in life sciences QA

PDCA is crucial for companies aiming for continuous improvement and regulatory compliance. It is commonly applied in validation processes, system upgrades, and risk assessments.

2. Root Cause Analysis (RCA)

Overview

RCA is a problem-solving methodology used to identify the underlying causes of defects or failures in a process. It focuses on determining the root cause rather than addressing symptoms.

Why it’s widely used

RCA is a standard practice in the life sciences for identifying and addressing the root causes of non-conformities, particularly during the implementation of Corrective and Preventive Actions (CAPAs). It helps teams focus on underlying issues, leading to more effective and long-lasting solutions.

Application in life sciences QA

RCA is commonly used to investigate compliance issues, such as validation failures. It is essential to ensure the effectiveness of CAPAs to prevent non-conformity recurrence.

3. Failure Modes and Effects Analysis (FMEA)

Overview

FMEA is a step-by-step methodology used to identify potential failures in a process, assess their impact, and determine corrective actions. It is a proactive approach to risk management.

Why it’s widely used

FMEA is a risk-based methodology crucial in life sciences for identifying potential failures in systems, processes, or devices. It aligns with the risk-based validation approach GAMP 5 and FDA regulations require.

Application in life sciences QA

FMEA is especially useful for assessing risks during CSV and equipment validation, ensuring that QA processes are robust, compliant, and capable of minimizing the likelihood of non-compliance.

4. Five Whys

Overview

The Five Whys technique involves asking "why" five times to drill down to the root cause of a problem. It is a simple yet effective method that encourages critical thinking by pushing teams to go beyond surface-level issues.

Why it’s widely used

The simplicity and effectiveness of the 5 Whys technique make it a popular tool in life sciences, especially when investigating the root causes of issues during CAPA investigations. It helps streamline the investigation process and ensures deeper problem-solving.

Application in life sciences QA

The 5 Whys is frequently used in root cause analysis to identify the fundamental causes of validation failures and compliance deviations.

5. Risk-Based Thinking (RBT)

Overview

Risk-Based Thinking (RBT) is an approach that focuses on identifying, evaluating, and mitigating risks within quality management systems. It is embedded in regulatory standards like GAMP 5 and ISO 13485.

Why it’s important

RBT is central to decision-making in the validation of computerized systems and is critical for ensuring compliance with risk-based regulatory standards. It allows organizations to focus resources on the areas of greatest risk, improving efficiency and compliance.

Application in life sciences QA

RBT is frequently used for CSV and risk assessments in life sciences, helping QA teams focus on high-risk areas that directly impact patient safety, product quality, and data integrity.

6. Cause and Effect Analysis (Fishbone Diagram)

Overview

Cause and Effect Analysis, also known as the Fishbone Diagram or Ishikawa Diagram, is a tool used to identify the root causes of a problem by breaking down and visualizing all possible contributing factors.

Why it’s widely used

This methodology is commonly used in life sciences to help teams understand the multiple factors that contribute to system or process failures, making it easier to identify and address root causes.

Application in life sciences QA

Fishbone Diagrams are often used during root cause analysis for validation failures, non-compliance issues, and to structure CAPA processes. It helps visualize the relationships between different causes and their effects on the problem.

Actionable insights for developing critical thinking

Takeaways

1

Embrace curiosity for continuous improvement

Like Leonardo da Vinci’s boundless curiosity, QA professionals should cultivate a mindset that encourages asking "why" and "how" to challenge established processes. Regularly questioning practices fosters innovation and helps identify opportunities for improvement, leading to more robust quality and compliance strategies.

2

Use data-driven insights to overcome resistance

Overcoming resistance to change requires clear, evidence-based communication. By demonstrating measurable benefits from process updates—such as improved compliance with GAMP 5 or FDA guidelines—QA teams can foster a culture of data-driven decision-making and continuous improvement.

3

Apply structured thinking to manage complexity

Managing the increasing complexity of regulations can overwhelm teams. By adopting structured approaches like Root Cause Analysis (RCA), Failure Modes and Effects Analysis (FMEA), and process mapping, QA professionals can break down complex challenges into manageable tasks, ensuring better compliance and patient safety.

4

Encourage open-mindedness to combat bias

Confirmation bias can hinder process improvement efforts. Regularly questioning assumptions, using tools like the Five Whys and peer reviews, can help QA teams reassess validation processes and make better, data-informed decisions. This open-mindedness leads to more effective CAPA implementations and higher standards of compliance.

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