Saturday, 9 March 2013

Operational Qualification (OQ) | Instrument and Equipment

Operational Qualification

Design Qualification Installation Qualification Performance Qualification
Operational Qualification is the part of instrument as well as equipment qualification and validation. So what is operational Qualification? It is the documented collection of activities which are necessary to  demonstrate that an instrument or equipment will function according to its operational specification in the selected environment.

Here during Operational Qualification more emphasis should be placed on " in the selected environment". Testing of instrument hardware at the user's site is required because instrument characteristics can change when shipped from the vendor to the user, for example through mechanical vibration.

Major activities which are conducted during Operational Qualification are as follows:

  • Tests that have been developed from knowledge or processes, systems and equipment.
  • It also contain tests to include a condition or a set of conditions encompassing upper and lower operation limits. 
  • Also includes tests such as  checking temperature Timer, and wavelength accuracy tests, and linearity testing.
  • It also include tests which verify the structural integrity of the equipment such as leak test (HPLC, GC Isolators etc.)
Some of the tests carried out during operational specification are (example HPLC) :
  1. Pump flow Accuracy and Precision.:  This test uses a calibrated digital flow meter to determine the accuracy and precision of solvent flow rate.
  2. Column Temperature Accuracy and Stability : This test uses a calibrated digital thermometer to determine the accuracy and stability of column temperature.
  3. Wavelength Accuracy:  This test uses a traceable standard or water to determine wavelength accuracy.
  4. Signal Noise and Drift: This test determines signal noise and drift.
  5. Injection Precision:  This test uses a traceable standard to determine injection carry over.
  6. Signal to Noise: This test uses a traceable standard or water to determine signal to noise.
  7. Response Linearity: This test uses a traceable standard to determine response linearity.
  8. Gradient composition: This test uses a tracer to determine solvent gradient composition accuracy, stability and linearity.
  9. Sample Temperature Accuracy: This test uses a traceable digital thermometer to determine sample temperature accuracy.
To get more details to know more about quality assurance also check DQ, IQ, OQ and PQ to know about calibration and validation.