Laboratory equipment qualification, also referred to as analytical instrument qualification (AIQ), is an essential component of good analytical practice. It provides assurance that the instrument will perform accurately and consistently in accordance with specifications and user requirements. The ultimate objective for equipment qualification is the documented and demonstrated assurance that the unit will produce valid data. Qualifications must be performed initially and on an ongoing basis (no less than annually).
It is recommended that laboratories develop a Master Qualification/Validation Plan. Part of the master plan should detail the laboratories approach to ensuring equipment is adequately qualified and controlled.
Most Master Plans identify and describe the following components for qualifying instrumentation:
- Design Qualification (DQ)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
Unless qualification is being performed retroactively, equipment qualification procedures should commence before instrumentation is purchased. A Design Qualification (DQ) Plan should be developed to ensure all the necessary functions and user specifications are defined for the intended application. This is a very critical step in the qualification plan. At this point, vendors should be assessed for quality and continued support. It is often helpful to ask for references and glean as much information as possible in regard do to reliability of the instrument, and technical and field support. Design considerations should also include instrument dimensions. For example, purchasing a piece of equipment that won’t fit through the door or in the allotted space could create huge setbacks in both time and money. Also, ensure that the environmental conditions required by the instrument can be met. Adding additional and unexpected temperature and/or humidity controls can become quite costly. An output of the DQ should be a detailed rationale for selection of a certain product.
Once the instrument is purchased, an Installation Qualification (IQ) should be developed. The IQ Plan should identify conditions and requirements for installation.
Examples of items to be considered and/or recorded for an IQ include:
- Required installation conditions (utilities, wiring, etc.)
- Verification that the instrument meets physical and construction requirements
- Safety features
- Environmental controls (i.e. required monitoring devices)
- Identification of spare parts
- Required standards and reagents
- Software/firmware versions
- Confirmation of receipt of the operator’s manual
- Spare parts list
Once equipment is properly installed and the IQ is completed and approved. The Operational Qualification (OQ) is launched. The goal of the OQ is to challenge the instrument operational parameters and functionality. It is important to simulate actual production conditions, including ‘worst case’ situations in order to adequately challenge the instrument. Tests should be repeated a sufficient number of times to assure reliability and meaningful results. Defined and pre-determined inputs are used to verify that the expected and desired outputs are elicited. OQ tests should have very specific acceptance criteria. Some tests are of the “Yes/No” variety while others are quantitative (e.g. wavelength accuracy and precision, flow rate accuracy, etc.). OQ test should also ensure that the security functions of the instrument are operating as designed.
The final test of equipment qualification is the Performance Qualification (PQ). This is when the instrument is put to the test for routine use. The PQ supplements the OQ by adding performance verifications using the actual method. The PQ is the final test to ensure the instrument performs as specified in a ‘real life’ situation. PQs should be repeated a sufficient number of times at various operating parameters to ensure reliability of data. The PQ should be designed to pose a significant challenge to the instrument to ensure it performs as specified and expected.
Once all tests are complete, a final qualification report (or however named) is written to include all test results. Any deviations that occurred during the course of the qualification should be discussed and a rationale provided for whether or not the deviation can be accepted. For a critical deviation, a corrective action report must be initiated. Critical deviations need to be resolved before the qualification is approved and released for use. If there are no major ‘show stopping’ deviations, the final qualification report is reviewed and approved by selected parties (e.g. management and QA) and the instrument is deemed qualified for use. It is important to remember that instruments must be re-qualified annually and after significant repair or relocation. If after repair, the decision is made to NOT re-qualify, it is important to record a rationale for that decision somewhere in the laboratory records.
An output of the qualification should be established procedures to include general operating instructions, system suitability, calibration, qualification, maintenance, training, etc. requirements.
Because qualification requirements are sometimes confusing, I always use the very simple example of qualifying a steam iron when describing DQ/IQ/OQ/PQ requirements. Very briefly and simply, the following studies would be considered for the qualification of a steam iron:
- DQ: This would include determining the features desired to include size and weight. It would also include reading consumer reviews and price comparisons.
- IQ: This would include a check to ensure all of the installation requirements are met and available. Examples would be checks for assuring proper space and available power outlets, possession of an ironing board, availability of water (for steam), an operator’s manual, etc.
- OQ: This would include checking to ensure all of the features operate as specified. Examples would be: Does it turn on when plugged in? Are the temperature settings correct? Does it make steam? etc.
- PQ: And finally, the PQ would put the steam iron to ‘real life’ test and that is, does it take the wrinkles out? In this example the PQ may include ironing a number of different fabrics at the various settings to determine if the iron performs as expected at all settings.
Again, that is a very simplified example, but it does describe the objectives of each study and how they are delineated. It is important to be proactive and methodical in your approach. In closing, always keep in mind that the objective of analytical instrument qualification is documented and demonstrated assurance that the unit will produce valid data in accordance with user requirements.