Critical Thinking: The Basis for New Regulatory Compliance
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Critical Thinking: The Basis for New Regulatory Compliance

Photo by:   Jaime Castro
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By Jaime Castro - BPF part of QbD group
Director General


"My father used to say 'Don't raise your voice, improve your argument.'" - Desmond Tutu


One of the most recurrent concerns among managers, directors and business owners has to do with the results obtained in the various areas of a company and how these impact on regulatory compliance, business and the satisfaction of customers and users of our products.

Effort, time and money are usually invested in correcting procedures, remedies, re-work process changes, personnel turnover, fines, customer complaints and many other situations of which we are not always sure of the cause but which are part of the daily happenings in the company.

In the health industries, most of the work in the operational and quality areas of the company has to do with knowledge, information management, measurement and scientific evaluation and implementation of processes and their related controls. Likewise, failures and errors are usually related to these same aspects.

During the documentary review of quality systems and Good Practices, as well as the evidence of their compliance, one of the most valued attributes is that of robustness. It is praised and exalted when a procedure, a protocol or a set of evidence is robust; however, we do not always have the clarity of what this concept of robustness implies. 

Robust results and evidence imply the fulfillment of some key attributes:

  • Complete, orderly, congruent and consistent information and data with the context and its background
  • With solid arguments that support the conclusions and results
  • Sufficient evidence and proof

But how do we achieve robustness in our processes, their results, documentation and regulatory compliance? Normally, the answer we give to this question has to do with "ordering it to staff" or in other cases we try many isolated actions (purchase of equipment, changes in processes, change controls, deviations, hiring new staff, etc.) that, in the best of situations, and with some luck, many attempts and money wasted, can result in the desired compliance. And well, this is where I allow myself to integrate the concept of critical thinking.

Critical thinking is defined as the systematic, rational and disciplined process of evaluating information from multiple perspectives to produce balanced and adequately reasoned responses. Another definition tells us that it is an intellectually disciplined process of conceptualizing, applying, analyzing, synthesizing and/or evaluating information to guide our convictions and actions. 

It is, therefore, a method for thinking and reasoning about information that allows us to make the best decisions.

Attributes of critical thinking:

  • Has a purpose
  • It arises from trying to solve a problem, answer a question or explain something
  • It is based on assumptions
  • It is backed up with data, information and evidence
  • It is expressed through concepts and ideas
  • It results in conclusions from inferences or interpretations
  • It has implications and consequences

Intelligence and knowledge do not necessarily imply reasoning or critical thinking. To pretend that the application of only one or the other is sufficient to obtain the best results is wrong, both intelligence and knowledge are complements and input elements for critical thinking. Good information will provide us with useful knowledge that, when used intelligently, will allow us, through reasoning, to construct robust arguments that support the conclusions with which we make correct decisions.

Reasoning is understood as the act of connecting information, to obtain the conclusions toward which it is directed. It is the act of connecting information to obtain conclusions. The statements resulting from exercising critical thinking must be sufficiently robust and solid to sustain themselves, allowing better decisions to be made and problems to be solved:

If we want to evaluate the quality of reasoning toward a problem, a theme or a situation, there are 10 universal intellectual values that we must consider:

  1. Clarity
  2. Accuracy
  3. Precision
  4. Consistency
  5. Relevance
  6. Solid evidence
  7. Logic
  8. Equity 
  9. Depth
  10. Extent

Steps to exercise critical thinking:

1. Be willing to adopt the attitude of a critical thinker which includes

  • Open mind
  • Healthy doubts
  • Intellectual humility
  • Confidence in reason 
  • Intellectual perseverance
  • Freedom of thought
  • High motivation and curiousity

2. Recognize and avoid major barriers and variations (cognitive biases)

3. Identify and characterize arguments

  • Argument = Reason + Conclusion 

4. Evaluate information sources and avoid speculations since an argument is only as strong as the data and information that give it origin
5. Evaluate the arguments to determine if the conclusions are guaranteed to be true and stand on their own, there is no information that has been omitted and that the reasoning carried out and its evidence are relevant and sufficient

People who want to develop critical thinking need to strengthen their skills in the cognitive skills of Interpretation, Analysis, Logical-critical reasoning, Evaluation, Inferences and Explanation

Likewise, it is important to define what critical thinking is not:

  • It is not a way to make people think alike
  • It is not a way to change one's personality and prejudices
  • It is not a belief, it is a procedure
  • It does not replace or minimize feelings and emotions but it can influence emotional decisions
  • It does not favor, represent or substitute scientific activities; it complements them and contributes with points of view that could be different from the scientific approach.
  • It is not necessarily persuasive
  • It is not dogmatic, doctrinal, orthodox, naive or credulous 

In view of the inclusive nature of critical thinking, it is important to include other people in the process who bring different points of view to reasoning so that it can be nurtured and lead to more meaningful conclusions. The multidisciplinary teams, which are widely mentioned in the history of quality systems and in the validation and qualification processes, have their support in the above.

In the search for truth, the processes of argumentation and reasoning may be affected by individual biases, such as interests or limited visions of the same problem. The task of those involved in the implementation and verification of regulatory compliance in the processes and products of the health industry is to hesitate until such compliance is demonstrated.

The aforementioned universal intellectual values ​​and the cognitive skills necessary for critical thinking become soft skills and fundamental competencies in those who work to guarantee the quality and safety of products related to human health.

The training and implementation of critical thinking processes in our day-to-day activities related to regulatory compliance and quality assurance is becoming an invaluable differentiator for better decision-making.

Seven universal intellectual standards and cognitive skills necessary for critical thinking have become soft skills and core competencies as part of the necessary evolution of those working to ensure the quality and safety of human health products. Critical thinking allows conscious decision-making through reflection, evaluation and analysis.

Some examples of situations in which critical thinking can make a difference in the outcome are:

  • When developing risk analysis, since it allows us to rule out biases or arguments that are convenient for the comfort of work or that force the result that we like the most instead of the most useful to avoid or reduce risks.
  • By arguing the robustness of our validation studies and the evidence presented to an auditor.
  • When we create our user requirements for a new equipment, process or system, reasoning which are truly important and necessary
  • During the creation of operating procedures to define the most significant activities of the process that will be mentioned in the procedure, as well as the controls and responsibilities required.
  • When the need for a change or the applicability of a non-conformity to a process is evaluated.
  • In the validation of computerized systems to determine the degree of compliance and the existing GAP towards the attributes of data integrity.

How can we implement critical thinking among our staff and in our organization?

  1. Next, I propose a decalogue of principles to begin work on this valuable paradigm shift: It starts with you.
  2. Create comfortable and suitable spaces for thought. Adequate lighting and space are helpful, providing tools that allow creativity and working with ideas.
  3. Ask, question, doubt and push your people to do the same. Blind trust, easy answers, bias and prejudice are the enemies of critical thinking.
  4. Exercise your argumentation by raising trivial and even funny problems that allow the confrontation of ideas and structuring of arguments. 
  5. Practice the change of focus in front of a problem by exercising positions opposite to their own. 
  6. Take adequate time to prepare the arguments and investigate their support; hurrying avoids deep analysis. Assigning time to reason and order thoughts should be part of the process.
  7. Guarantee the freedom of opinion and autonomy to search for answers.
  8. Provide access the necessary end correct information to build solid arguments based on knowledge.
  9. Include in your job descriptions the competencies, attitudes and skills necessary for the exercise of critical thinking (such as effective communication, openness to ideas, self-knowledge, proactivity, liking for reading organization, discipline, analytical capacity, etc.), and develop them among your current collaborators and for new ones to have a similar profile that facilitates their implementation. 
  10. Evaluate and recognize your company's critical thinkers. Remember, "If you pay peanuts..."

In summary:
The adoption of critical thinking within the culture of the company and especially in the processes related to quality, production and regulatory compliance allows the people involved to make, in a conscious and rational way, better decisions that increase the efficiency, effectiveness and quality of the results in processes.

Photo by:   Jaime Castro

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