Instrument qualification is not a single continuous process, but instead results from several discrete activities. For convenience, these activities can be grouped into four phases: design qualification (DQ), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).
Installation qualification (IQ) is the documented collection of activities necessary to establish that an instrument is delivered as designed and specified, and is properly installed in the selected environment, and that this environment is suitable for the instrument. IQ applies to an instrument that is new or was pre-owned, or to any instrument that exists on site but has not been previously qualified. Relevant parts of IQ would also apply to a qualified instrument that has been transported to another location or is being reinstalled for other reasons, such as prolonged storage. The activities and documentation typically associated with IQ are as follows.
Provide a description of the instrument or the collection of instrument components, including its manufacturer, model, serial number, software version, and location. Use drawings and flow charts where appropriate.
Ensure that the instrument, software, manuals, supplies, and any other instrument accessories arrive as specified in the purchase order and that they are undamaged. For a pre-owned or existing instrument, manuals and documentation should be obtained.
Verify that the installation site satisfactorily meets manufacturer-specified environmental requirements.
Assembly and Installation
Assemble and install the instrument, and perform any preliminary diagnostics and testing. Assembly and installation may be done by the manufacturer, vendor, specialized engineers, or qualified in-house personnel. Manufacturer-established installation tests and guides provide a valuable baseline reference for determining instrument acceptance. Any abnormal event observed during assembly and installation merits documenting. Installation packages purchased from the manufacturer or the vendor may, however, need to be supplemented with user-specific criteria.
Network and Data Storage
Some analytical systems require users to provide network connections and data storage capabilities at the installation site. When required, connect the instrument to the network, and check its functionality.
Perform the initial diagnostics and testing of the instrument after installation.
After a successful IQ, the instrument is ready for OQ testing. Operational qualification (OQ) is the documented collection of activities necessary to demonstrate that an instrument will function according to its operational specification in the selected environment. Testing activities in the OQ phase may consist of these test parameters.
These tests measure the instrument's nonchanging parameters such as length, height, weight, voltage inputs, acceptable pressures, and loads. If the manufacturer-supplied specifications for these parameters satisfy the user, the test requirements may be waived. However, if the user wants to confirm the parameters, testing can be performed at the user's site. Fixed parameters do not change over the life of the instrument, and therefore never need redetermination. [note
These tests could also be performed during the IQ phase (see Table 1
); if so, fixed parameters need not be redetermined as part of OQ testing.]
Secure Data Storage, Backup, and Archiving
When applicable, test secure data handling such as storage, backup, audit trails, and archiving at the user's site according to written procedures.
Instrument Function Tests
Instrument functions required by the user should be tested to verify that the instrument operates as intended by the manufacturer. Manufacturer-supplied information is useful in identifying specifications for these parameters and in designing tests to evaluate the identified parameters. Users, or their qualified designees, should perform these tests to verify that the instrument meets manufacturer or user specifications in the user's environment.
The extent of OQ testing that an instrument undergoes depends on its intended applications. Therefore, no specific OQ tests for any instrument or application are offered in this chapter.
Routine analytical tests do not constitute OQ testing. OQ tests are specifically designed to verify the instrument's operation according to specifications in the user's environment, and repeating the testing at regular intervals may not be required. However, when the instrument undergoes major repairs or modifications, relevant OQ and/or PQ tests should be repeated to verify whether the instrument continues to operate satisfactorily. If an instrument is moved to another location, an assessment should be made of what, if any, OQ test should be repeated.
OQ tests can be modular or holistic. Modular testing of individual components of a system may facilitate interchanging of such components without requalification. Holistic tests, which involve the entire system, are also acceptable.
Performance qualification (PQ) is the documented collection of activities necessary to demonstrate that an instrument consistently performs according to the specifications defined by the user, and is appropriate for the intended use. After IQ and OQ have been performed, the instrument's continued suitability for its intended use is demonstrated through performance qualification. The PQ phase may include the following parameters.
Set up a test or series of tests to verify the acceptable performance of the instrument for its intended use. PQ tests are usually based on the instrument's typical on-site applications and may consist of analyzing known components or standards. The tests should be based on good science and reflect the general intended use of the instrument. Some system suitability tests or quality control checks that are performed concurrently with the test samples can be used to demonstrate that the instrument is performing suitably. PQ tests may resemble those performed during OQ, but the specifications for their results may be set differently if required. Nevertheless, user specifications for PQ tests should demonstrate trouble-free instrument operation for the intended applications. As is the case with OQ testing, PQ tests may be modular or holistic.
Testing frequency depends on the ruggedness of the instrument and the criticality of the tests performed. Testing may be unscheduledfor example, each time the instrument is used. It may also be scheduled for regular intervals. Experience with the instrument can influence this decision. It may be useful to repeat the same PQ tests each time the instrument is used so that a history of the instrument's performance can be compiled. Alternatively, the instrument may be incorporated into an integrated support system to assure that it remains continually qualified. Some system suitability tests or quality control checks that are performed concurrently with the test samples also imply that the instrument is performing suitably.
Preventive Maintenance and Repairs
When an instrument fails to meet PQ test specifications, it requires maintenance or repair. A periodic preventive maintenance may also be recommended for many instruments. The relevant PQ test(s) should be repeated after the needed maintenance or repair to ensure that the instrument remains qualified.
Practices for Operation, Calibration, Maintenance, and Change Control
Establish practices to maintain and calibrate the instrument. Each maintenance and calibration activity should be documented.