The Contents and Steps of 3Q Certification for Laboratory Instruments

1., 3Q content

If it is a complete set of instrument (or equipment) verification scheme, it will include 4 parts, that is, 4Q, respectively:

DQ, design confirmation (Design Qualification), confirm that the design of the equipment meets the requirements of user requirements and relevant regulations.

IQ, installation confirmation (Installation Qualification), confirm the instrument files, parts and installation process.

OQ, operation confirmation (Operational Qualification), confirm that the instrument can operate normally within the limit range of operation.

PQ, performance confirmation (Performance Qualification), to confirm whether the operation of the instrument is in accordance with the standard.

Because the instruments used in the laboratory are all developed by the instrument manufacturer, therefore, DQ (design confirmation) can not be done in the instrument verification, so the 3Q mentioned in this paper refers to the above IQ (installation confirmation), OQ (operation confirmation) and PQ (performance confirmation). That is to say, laboratory instrument verification starts from IQ (installation confirmation), and then performs OQ (operation confirmation) and PQ (performance confirmation), and completes a set of instrument validation data.

2.. Introduction of the classification of verification instruments

For laboratory instruments, according to the classification of the instruments, they are divided into 3 categories.

For simple instruments, such as electric stove, ultrasonic cleaner, etc., it is not necessary to verify, because the instrument itself is simple and has no direct effect on the test results, so this kind of instrument can be omitted.

For general instruments, such as: pH, balance is not a precision instrument, but also on the instrument state test results can have a direct impact, so that the instrument need to do 3Q verification, but can be simple to do, is to do: IOQ, PQ, or IQ (installation qualification) and OQ (OQ) synthesis of a the steps to do.

For precision instruments, such as liquid chromatograph, gas chromatograph and other precision instruments, 3Q verification should be done, namely, IQ (installation confirmation), OQ (operation confirmation) and PQ (performance confirmation).

3., 3Q validation steps

After determining the instrument that needs to be verified, we need to know what each step of the 3Q validation needs to do.

1.IQ (installation confirmation), as its name implies, is to confirm (or verify) the installation process of the instrument.

The first is the paper documents, can be listed in the form, including equipment manufacturers of instrument materials, testing certification materials; equipment manufacturers specifications, packing list and accessories list; standard operating procedures, use of departments to compile the maintenance records, records, personnel training and other documents or other parts of the instrument; calibration certificate.

Secondly, the preparation of the external environment is confirmed, such as room exhaust, temperature and humidity control, electricity supply, unexpected power outage emergency measures and so on.

In the end, it is the confirmation of the parts of the instrument itself, according to the specifications and the characteristics of the instrument itself, to check whether the above preparation work is completed and reasonable.

2.OQ (operation confirmation) is mainly designed to verify that the instrument can achieve good operation in the limit of instrument design under the condition of idling, that is, a minimum limit and maximum limit test.

Here we need to use many metering devices to confirm some functions of the instrument, such as temperature. We need to use an external temperature device to verify the highest temperature and minimum temperature designed by the instrument itself, and whether it is in the design range. For example, sample volume, if the injection volume is large, we can use the calibrated calibrated instrument to confirm. If the volume is small, it is necessary to confirm by indirect method, for example, the accuracy of liquid phase sampling can be confirmed by continuous injection of standard sample.

3.PQ (performance confirmation)

For instruments only, this step can be simply understood as the actual samples of OQ (operation confirmation), because this step is to test the samples, with known concentration of sample, to verify the accuracy of the instrument is unknown; the concentration of the sample, to verify the ability of detecting instrument. In a simple way, it is the process of testing one or two times according to the method of sample testing. In general, the IQ (installation confirmation) and the OQ (run confirmation) are done, and the PQ (performance confirmation) can be passed smoothly.