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ROI CalculatorPerformance qualification is establishing the necessary level of confidence through adequate testing to verify that the final output from a particular procedure or method has met all requirements for the output regarding its safety and functionality as well as that all of the methods used to generate the final output are reproducible and effective.
The purpose of performance qualification is to California your product so that under real-world usage, and under normal working conditions, your device can consistently produce accurate results. For this reason, performance qualification must be performed under conditions that closely resemble real-world usage of the device. This includes conducting the qualification in the same location where your product will be used; with staff trained on how to use the product correctly; using the device in the way it was designed to be used and under the same manufacturing conditions as it was originally manufactured.
What tests are conducted during performance qualification will depend on the type of device being qualified. Therefore, when developing a performance qualification program, companies need to take into account their intended uses and user/patient demographics, as well as their device's environmental characteristics before developing a performance qualification protocol.
Generally, performance qualification should consider the following:
Product and process parameters and procedures established during operational qualification
Product acceptability
Process capability assurance as established in operational qualification
Process repeatability and long-term process stability
A performance qualification could demonstrate:
That a system can handle multiple users without system issues or lag
That concurrent workflows don't affect each other
That a test correctly identifies a known material
That devices work correctly and within defined system requirements during real-world use
Some potential nonconformities that can be identified during performance qualification include:
Excessive heat
Excessive vibrations or noise
Pressure differential
Process media back-flow
As per FDA guidelines (FDA Guideline 111), there are some recommended minimum guidelines for the development and establishment of written protocols for performance qualification. These protocols should provide detailed descriptions of the activities and conditions associated with performance qualification. This could include:
Manufacturing conditions and operational parameters, such as device limits and component inputs
Description of the requirements for demonstrating repeatability and stability
Standard operating parameters and limits
Time frame and testing schedule
Variability limits
The raw materials used in the manufacturing process
Which tests you will use to test the device, and the acceptance criteria for each
Calibration and validation tests to endure quality throughout production
Which data you will collect during tests, calibration, and validation, and how you plan to assess it
A sampling plan to ensure confidence in the quality within and between batches
Facility designs and plan for personnel qualification and training
Criteria for how you will assess the efficacy of the process and making science- and risk-based decisions
Validation status of the analytical methods used, including justifications for any data or statistical tools employed during tests
Plans for how to handle non-conformities, as well as remediation procedures
Acknowledgements and review and approval status by the relevant personnel and departments
It is widely expected that the results from performance qualification's documentation should reflect the work performed during performance qualification. Each instance of performance qualification should have its own set of instructions and an expected outcome. In cases where a variance was discovered between the expected and actual outcomes, those variances should also reflect and follow the same format for documentation and resolution, prior to the conclusion of validation.
Determining the range of normal variation in the data resulting from performance qualification requires analysis. The analysis results allow for determining and maintaining the normal operating state or condition for the device or process and its ability to consistently produce the desired output within the specified tolerances. Variations that can be controlled by using various factors, such as temperature, humidity, type of light used, types of materials used, etc., should be eliminated to achieve a higher level of consistency and assurance with respect to a device's performance during any type of application.
