Discover the Science behind Calibration, Testing, and Validation Processes.
Calibration, testing, and validation are intertwined within the science field, and it can be complicated when looking at the differences and actual meanings. Each activity ensures quality in the measurement process and complies with a standard’s requirements.
Calibration the Scientific Definition
In the first step, the operation under specified conditions establishes a relation between the quantity values with measurement uncertainties provided by measurement standards and corresponding indications with associated measurement uncertainties.
The second step uses this information to establish a relation for obtaining a measurement result from an indication.
When a measurement device is calibrated, it is compared to an accepted standard, and adjustments are made if necessary. Therefore, it is imperative to use a lab that has ISO 17025 accreditation. This accreditation means that a third party has evaluated the laboratory’s quality management system and technical competence.
The Definition of Testing and Functional Testing
A technical operation determines one or more characteristics of a given product, process, or service according to a specific procedure.
Functional testing determines if it is functioning correctly. The testing involves exposing the item to a stimulus and verifying that the equipment responds accordingly.
Definition of Validation
Validation is for “ensuring” the acceptability of the implemented measurement process. It is the combined effect of calibration and verification. Still, the final result is in the final output of the process.
The application in the calibration field is more on developing a calibration procedure to meet specific requirements.
A non-standard method can be used in a calibration laboratory, considering it is validated before use. Another validation application is qualifying a group of measuring devices that function as a system.
Considerations During Calibration
The traceability and the computed measurement of uncertainty must be considered during calibration. Customer requirements and regulatory authorities guide your objective in performing calibration.
It is also by calibration procedures based on standard methods and techniques from manufacturers or original equipment manufacturers.
The steps performed during calibration:
- Choose the required calibration procedure to be used.
- Compared to a reference standard
- Determine the error
- Adjust if capable
- Check the traceability
- Estimate measurement uncertainty.
- Record results to a calibration certificate.
Techniques Used for Method Validations per ISO 17025
- Calibration or evaluation of bias and precision using reference standards or reference materials
- Systematic assessment of the factors influencing the result.
- Testing method robustness through variable controlled parameters, such as incubator temperature and volume dispensed.
- Comparison of results achieved with other validated methods.
- Interlaboratory comparisons
- The evaluation of measurement uncertainty is based on an understanding of the theoretical principles, methods, and practical experience of the performance of the sampling or test method.
Calibration, Testing, and Validation
All of these three are performed to ensure quality in the measurement process and comply with the requirements of a standard. These standards are ISO 17025 and ISO 9001. Understanding each makes interpreting the standards easier and when each is used within the process. If you ever have any questions about calibration or equipment, we are available to help. At SRP Control, we have been helping our clients with products, services, measurements, and calibration solutions for the past 40 years. Let us help you find the following instrumentation or calibration solution.