What is a Qualification Assessment?
Suppose there was no scalpel when performing the surgery.（It’s impossible, but…It’s impossible, but…）
I bought a top-of-the-line knife at a local high-end cutlery store. Since it is top quality, of course the quality will be good.
However, is a high quality knife suitable for surgery?
The answer is no.
Also, let’s say you want to tighten a Phillips-head screw, but you don’t have a Phillips-head screwdriver. A Phillips screwdriver would also be able to tighten a Phillips-head screwdriver.
However, if this is repeated, the screw holes may be crushed. Furthermore, the screwdriver itself could be damaged. This would cause accidents.
There is a risk of accidents occurring if the specifications of the equipment, etc. do not match the intended use (Intended Use).
Regulatory requirements always require “specifications” to match “requirements,” and confirming that they have been met is called “qualification” (Qualification).
In other words, validation for hardware (not hardware) is called “qualification”.
Hardware is primarily made of hardware. When said hardware is controlled by software (or firmware, PLC, etc.), it is called a computerized system (or automated system).
In such cases, a “Qualification Study” (CSV) is also required for such software.
Qualification is a term used in process validation and consists of DQ (Design Qualification), IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification). Qualification (Operational Qualification: Operational Qualification), and PQ (Performance Qualification: Performance Qualification).
In modern times, DQs and PQs are often not implemented.
PQ can also be included in OQ and process validation (PV).
Furthermore, IQ and OQ are allowed to be conducted simultaneously, and it is common practice to defer to the supplier of the hardware (including software) in question as IOQ.
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