What is critical thinking?
Critical thinking is now attracting attention in the United States, along with logical thinking.
In Japanese, this is translated as “critical thinking. However, it does not mean denying everything.
The key to critical thinking is to eliminate assumptions and question presuppositions.
To achieve this, it is necessary to always be aware of what the objective is and to think objectively.
Assumptions, prejudices, and existing values must be eliminated and other factors considered.
In other words, we must always keep asking, keep thinking, and keep considering whether this is the best thing to do.
Characteristics of people who are incapable of critical thinking include those who are stubborn and those who are quick to take the opinions of others for granted.
The design of “Scotty” was determined by critical thinking.
Sanyo Scott Company (at that time) held an international competition for the renewal of its tissue paper “scottie” package, gathering about 20 designers from around the world.
It was decided that the prerequisites for the design were to be floral and to use the given logo.
Mr. Makoto Matsunaga, a participant in the competition, said, “Floral patterns are fine in a simple room where nothing is placed. But in a messy room, if tissue paper, which is used as a daily commodity, were flower-patterned, it would be a distraction. He thought about it.
What I would have liked to have had was a simple, plain white box that I could have sauced in a corner of my room.
Furthermore, the logo that SanyoScott had prepared was not quite right. Therefore, Makoto Matsunaga reworked the logo from scratch.
The logo was designed to be soft with the “gentleness” and “smoothness” that tissue paper must have.
This has become the current “scottie” package. By eliminating both of the prerequisites “to be floral” and “to use a given logo,” critical thinking was used to determine what the original tissue paper package should be.
FDA Expectations
FDA feels that “too much work is being done, not for fear of putting poor quality products on the market, but for fear of being singled out for inspection.” It feels that
Many companies try to avoid FDA inspections with Form 483s, warning letters, and third-party consultants.
However, there is nothing that should be done for fear of being pointed out by the authorities.
Rather, critical thinking should be used to focus on appropriate risk-based quality assurance for patient safety and product quality.
According to an FDA survey, the better a company’s risk management practices, the better its quality.
Such companies have fewer complaints and recoveries, and therefore fewer people in their quality assurance departments.
Why don’t the authorities set standards?
As in the past, regulatory requirements and guidelines no longer set the “standard.
In the future, companies will have to set their own “standards” based on a risk-based approach.
Rather than adhering to a given standard, they need to think for themselves what is inherently important to ensure patient safety and product quality.
The FDA expects the following
Employees of pharmaceutical companies are professionals in their own products. They are experts in the process.
The person in charge should know better than the FDA inspector how much risk there is in the product and in the process concerned.
Quality assurance should be conducted not by the authorities, but by the companies themselves, by setting “standards” appropriate to the risks involved. (risk-based approach).
The FDA would like the inspector to explain the level of quality assurance concerned with justifiable grounds.
Critical thinking is the consideration of where risks may be posed and what the product or process risks are.
The company must be able to provide a reasoned explanation to the FDA inspector, i.e., demonstrate that it understands and has elements of control over the product and the process in question.
The FDA wants to know that the company really understands the process in question and that the company is managing it itself. It is important to be able to communicate to the FDA inspectors that you know where the risks lie.
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