About Blind Compliance

About Blind Compliance

In my consultations with pharmaceutical and medical device companies, I often find that Japanese companies blindly follow the rules, i.e., “Blind Compliance“.
It is a characteristic of the Japanese that they are comfortable with some kind of standard or criteria, and they will blindly adhere to those criteria or criteria. The Japanese are often fond of standards.
GMP in Japan is named “Standards for the Manufacturing Control and Quality Control of Pharmaceutical Products . However, no criteria are listed anywhere in the GMP text.
When the author conducts seminars and consultations, he is often asked, “Are there any good criteria for making judgments?” I am often asked the question, “Are there any good criteria for making a decision?
It would be easier for them to be shown the standards. They have given up thinking for themselves.

risk-based approach

Today is the age of the risk-based approach.
The time and effort cost of compliance should be different for each company according to the risks of the products and processes they manufacture and sell.
The criteria for making those decisions must also be presented with evidence.
The MHLW’s “Computerized Systems Good Management Practices Guideline“, you can find the categorization is indicated. The idea is that different categories have different deliverables that should be created.
However, there are absolutely no examples of the use of categorization in regulatory requirements for computerized system validation (CSV) in other countries.
Most regulators require a risk-based approach.
Given some standard, Japanese companies will try to comply and follow it.
In other words, Japanese companies are extremely poor at thinking for themselves.
When the author conducts consultations and asks why the process is the way it is when referring to SOPs, he often receives responses such as, “I don’t know, but we have been doing it this way for a long time.
This is because they do not consider the purpose or goal of their own work or operations.

critical thinking

Japanese firms are critical thinking (critical (critical thinking) is also a weak point.
In critical thinking, it is also important to question assumptions.
It is important to always consider what the purpose of the process or operation in question is.
An important aspect of the manufacture of pharmaceuticals and medical devices is to assure their quality and patient safety.
It is never about creating a lot of records unnecessarily. Most of the records will not be used afterwards and will be created merely for the purpose of undergoing inspections.
Companies should not be working for the sake of inspections, but only for the sake of patients and users.
There are also many questions about which records need to be signed, whether handwritten signatures are required for approval, and whether signed records must be shown during FDA inspections.
Those questions are nonsense. Signatures do not directly affect product quality or patient safety. The results are not important, but the procedures are important.
If the FDA inspector asks for a copy of the record, you can simply hand over a copy of the signed original. It does not mean that you have to find the signed (paper) record and show the signature to the inspector during the inspection.

The design of “Scotty” was determined by critical thinking.

An international competition was held for the renewal of the tissue paper “scottie” package, bringing together about 20 designers from around the world.
The prerequisites for the design were communicated: that it be floral and that the given logo be used.
Mr. Makoto Matsunaga thought that a flower pattern would be fine in a simple room without any objects. However, he thought that if tissue paper, which is used as a daily necessities in a messy room, had a floral pattern, it would be a distraction.
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 did not meet their standards. Mr. Makoto Matsunaga had to recreate the logo from scratch.
The logo was designed to be soft with the “gentleness” and “smoothness” that tissue paper must have.
As a result, Makoto Matsunaga won the competition and was selected to design Scotty’s.
Critical thinking is required to question assumptions and preconceived notions, and to ask what the original purpose or goal is.


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