What is Quality Assurance?
QA stands for Quality Assurance.
Often, there is a misconception that quality assurance is provided through audits (Audit).
If auditing is quality assurance, why not call it Quality Audit?
Audits are part of quality assurance, but not all. One should not confuse auditing with quality assurance.
So what exactly is assurance?
Assurance is guidance (advice) by someone with experience and skill.
In other words, they are deeply involved in the process and endorse its quality on behalf of the department concerned.
GLP was probably the earliest to adopt the concept of Assurance in the pharmaceutical industry.
The GLP exam is difficult and not everyone can do it. Let’s say there are 10 tests. If two people divide these tests, there will be some that can be done well and some that cannot be done at all.
Therefore, an accustomed and skilled person was assigned as Study Director (SD) to guide the test administrators.
In other words, they are instructed on how to write a test plan, how to conduct a test, and how to write a test report.
This results in uniform quality in all tests.
Quality assurance personnel are accountable to customers and regulatory authorities.
For example, suppose a reader makes a purchase. However, there was a quality problem and he filed a complaint. What would you think if the company explained, “The quality is not good because it was made by a newcomer who is not familiar with the product.” What would you think if the company explained, “The quality is not good because it was produced by a newcomer who is not familiar with the product. Perhaps you would demand, “The company should guarantee the quality of the product instead of putting the blame on the person in charge of the product. The company would probably demand that the company assure the quality of the product, instead of putting the blame on the person in charge.
A company will have a variety of employees, including newcomers, the unfamiliar, and those who are not suited for the job. However, we cannot afford not to let them do their jobs.
No matter who is in charge of manufacturing, the quality assurance personnel must ultimately guarantee the quality of the product on behalf of the person in charge.
Quality assurance personnel must monitor and oversee the process and must not approve the shipment if he/she is not confident of the quality.
QA Case Study Suppose the reader is about to undergo LASIC surgery (laser surgery for myopia). The doctor in charge at the ophthalmology clinic we visited was very inexperienced, having performed less than 100 surgeries, and we felt uneasy. The director of the clinic in question is said to be very experienced, having performed more than 10,000 laser operations. Naturally, we would have preferred to have the director perform the surgery rather than a new doctor.
However, the director does not perform many surgeries himself anymore. This is because he is busy managing the hospital and its staff. If the director continues to perform surgeries, new doctors will not be trained.
In such a case, you would probably say, “Then, at the very least, the director should be present at the surgery to ensure that the new doctor doesn’t screw up.” In such a case, the new doctor would probably demand, “Then at least have the director attend the surgery so that the new doctor does not fail. In this way, the director attends the surgery, gives advice, and leads the new doctor to a successful operation so that he or she does not make mistakes. This is Quality Assurance.
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