Definition and Importance of Logical Thinking
Logical thinking, in Japanese “ロジカルシンキング” (rojikaru shinkingu), refers to the systematic approach of reasoning and argumentation. For instance, when persuading people, one’s “logic” must be coherent and sound. A “論文” (ronbun, academic paper) is literally a “logical document”—a text designed to make others understand and be convinced.
Logic is indispensable when you want to make someone say “yes,” when you want them to understand your feelings, or when you need them to take action. For example, “Take an umbrella! You don’t want to get wet, do you?” is also logic. By providing a reason, the listener is more likely to comply with the request.
In fact, we realize that even children use logical thinking in their daily lives. When a child says, “Mom, please buy me that toy. Everyone else has one…”, they are using a reason to persuade. This illustrates that logical thinking requires both “Why” (the reason) and “So What” (the desired outcome or action).
The Role of Logical Thinking in the Regulatory Environment
In the pharmaceutical and medical device industries, logical thinking forms the foundation of regulatory compliance and quality assurance. International guidelines from the International Council for Harmonisation (ICH), regulations from the FDA (U.S. Food and Drug Administration) and EMA (European Medicines Agency), as well as international standards such as ISO 14971 (Risk Management for Medical Devices), are all built upon logical thought processes.
The Importance of “Why”
A narrative without “why” is difficult to comprehend. The same applies to seminars and training sessions. A truly knowledgeable instructor (one who delivers comprehensible seminars) will first explain “why” regulatory requirements have been issued and “why” certain demands exist.
However, many instructors focus predominantly on “What” (what needs to be done). This is hardly different from merely reading documents aloud. For instance, simply enumerating the requirements of FDA 21 CFR Part 11 (regulations concerning electronic records and electronic signatures) or cGMP (current Good Manufacturing Practice) does not lead to an essential understanding of “why data integrity is important.”
When I conduct consultations at companies and review their SOPs (Standard Operating Procedures), I often ask, “Why is the process structured this way?” The response I frequently receive is, “We don’t know why, but our company has always done it this way.” In other words, they don’t understand the “Why.” Only the “What” has been passed down. This means they not only fail to grasp the essence of their operations but also cannot determine whether they comply with regulatory requirements.
Risk-Based Approach and Logical Thinking
ISO 14971:2019 (Application of Risk Management to Medical Devices) and ICH Q9 (Quality Risk Management) emphasize the importance of a risk-based approach. These standards require not merely identifying risks but also logically explaining “why the risk exists” and “why the control measure is appropriate.”
ISO 14971 requires logical thinking throughout the entire risk management process:
| Process Stage | Required Logical Thinking | Regulatory Relevance |
|---|---|---|
| Risk Analysis | Why: Why does this hazard exist? | Systematic identification of hazards |
| Risk Evaluation | What: What could happen? | Assessment of probability and severity |
| Risk Control | How: How should it be controlled? | Implementation and verification of control measures |
| So What | So What: Is the residual risk acceptable? | Benefit-risk analysis implementation |
Understanding Inspection Findings
While many inspection observation cases from regulatory authorities are widely discussed, true improvement is impossible without understanding “why” the observation was issued. For example, FDA Form 483 observations or EMA inspection findings that simply state “non-compliance” are insufficient.
Understanding what the regulatory authorities are concerned about (Why), what quality risks exist (What), and how improvements should be made (How) logically leads to genuine corrective and preventive actions (CAPA).
The Danger of “How”-Centered Approaches
There are also seminars and training sessions that focus predominantly on “How” (how to do it) without explaining “Why” or “What.” “How” is the most concrete and can create an illusion of understanding. However, without understanding the essence, one may become lost when attempting implementation.
For instance, when teaching validation (qualification) procedures, merely instructing “use this format and fill it in this way” (only “How”) without understanding “why validation is necessary” or “what is being verified” leaves one unable to respond to unexpected situations.
The Need for Analytical Thinking and Problem-Solving Skills
The World Economic Forum has identified key skills necessary for the future of work, including analytical thinking and innovation, active learning, complex problem-solving, critical thinking and analysis, creativity, originality, and initiative. All of these skills are crucial for pursuing careers in the pharmaceutical and medical device industries.
In the era of digital transformation (DX), regulatory professionals need to enhance their competencies not only in digital literacy skills such as data visualization, statistical data analysis, and data mining, but also in complex reasoning and problem-solving, adaptive thinking, agility, communication and teamwork, and leadership and initiative—all elements of what are known as 21st-century skills.
Integrated Understanding of Why-What-How
Effective logical thinking requires an integrated understanding of Why-What-How. In a regulatory environment, one should think as follows:
Why (Why): The rationale and purpose of regulatory requirements
- Example: Why is GMP/QMS (Quality Management System) necessary? → To ensure patient safety
What (What): Specific requirements
- Example: What needs to be implemented? → Qualification, process validation, change control, etc.
How (How): Implementation methods
- Example: How should it be implemented? → Creating, executing, and documenting qualification protocols
So What (So What): Conclusion and action
- Example: What should be decided based on these results? → Confirm system qualification and obtain manufacturing authorization
Conclusion
Logical thinking is the foundation of regulatory compliance, quality assurance, and risk management in the pharmaceutical and medical device industries. Knowing not only “What” and “How,” but also understanding “Why” cultivates true expertise and problem-solving capabilities.
Regulatory requirements are constantly evolving, and to comply with the latest international standards and guidance such as ISO 13485:2016 (Quality Management Systems for Medical Devices), ISO 14971:2019, and ICH Q8/Q9/Q10, continuous learning and the practice of logical thinking are essential. Cultivating an organizational culture that continuously asks “why” leads to the construction of a sustainable quality culture.
In training sessions and seminars, the Why-What-How-So What framework should be employed to ensure comprehensive and logical knowledge transfer. This enables participants to acquire practical capabilities based on essential understanding rather than mere memorization of procedures.
Regulatory References and Standards Mentioned
International Harmonization:
- ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use): Harmonizes regulatory standards across regions including Europe, Japan, and the United States
- ICH Q8: Pharmaceutical Development
- ICH Q9: Quality Risk Management
- ICH Q10: Pharmaceutical Quality System
Regulatory Bodies:
- FDA (U.S. Food and Drug Administration)
- EMA (European Medicines Agency)
- 21 CFR Part 11: Electronic Records and Electronic Signatures
- 21 CFR Part 820: Quality System Regulation (QSR)
- FDA Form 483: Inspectional Observations
International Standards:
- ISO 13485:2016: Medical devices – Quality management systems – Requirements for regulatory purposes
- ISO 14971:2019: Medical devices – Application of risk management to medical devices
- ISO/TR 24971:2020: Guidance on the application of ISO 14971
- cGMP: Current Good Manufacturing Practice
European Regulations:
- MDR 2017/745: Medical Device Regulation
- IVDR 2017/746: In Vitro Diagnostic Medical Device Regulation
Key Concepts:
- CAPA: Corrective and Preventive Actions
- QMS: Quality Management System
- SOP: Standard Operating Procedures
- Data Integrity: Ensuring the accuracy, consistency, and reliability of data throughout its lifecycle
- Risk-Based Approach: Decision-making methodology that prioritizes resources based on risk levels
- Validation: Establishing documented evidence that provides high degree of assurance that a specific process consistently produces a product meeting predetermined specifications
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