Quality control is the function of producing products with quality that satisfies customer requirements and providing them to customers.
In Japan, I often feel that this QC is mistaken for QualityCheck.
You know that this is wrong and that Quality Control is correct.
Many Japanese pharmaceutical companies use double-entry data entry and read-checking several times to correct input errors.
However, this process is only a Check, not a Control as in QC.
The difference between Check and Control is obvious.
Control refers to a function that manages and operates business processes in accordance with SOPs and other standards, and returns them to normal when there is a deviation from these standards.
The same checks are conducted in the written survey after a new drug application, but quality (control) related to the process does not seem to be reviewed.
This is a major difference between the Japanese and U.S. approaches.
Incidentally, the Japanese translations of “Manage” and “Control” are both “management,” but the difference is this.
Manage can be compared to a baseball coach and Control to a pitcher.
In other words, Manage is the role of commanding and controlling the entire operation (e.g., directing the salute), and Control is the role of performing the work as directed (e.g., throwing strikes).
As can be seen, the role of the QC person is to point out when a business process deviates (or seems to deviate) from the SOP and guide it to the correct process.
It is never about finding data entry errors.
If data entry errors are generally corrected by other departments (in this case, the QC department) rather than the department responsible for the entry, the quality of data in the process is less likely to improve.
The principle is that the data source is responsible for the quality of the data.
In the next issue, we will discuss quality assurance (QA).