Why outsource IQ-OQ-PQ testing?
This FAQ is inspired by a client discussion about onsite Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ). They asked me to define the benefits they would see if they engaged ViVitro to perform IQ-OQ-PQ instead of doing it themselves.
I think the core value of completing the process and why it should be done by an experienced third party is confidence. In this FAQ I will quickly highlight how completing each step can give confidence in both your process and results.
Performing installation qualification will ensure that the space where you have installed your equipment is suitable for testing and will not impact the device performance. Completing installation qualification will give you confidence in your facility, by ensuring a noise free stable test platform. We will review your calibration and maintenance schedules, and test protocol.
Electronic measurement in a lab can be complex and frustrating. As an example, many test systems use electromagnetic flowmeters due to their insensitivity to changes in fluid density, temperature, pressure and viscosity. However, these flowmeters have a very low voltage output, typically in microvolts, which can easily be lost due to nearby noise sources. They are also reliant on a conductive ground path, a feature many buildings still lack.
Lack of grounding and external noise are common issues we find when users are having difficulty during calibration or technical review. This process should be completed prior to training to prevent user error, system damage and unnecessary downtime.
Operation Qualification will give you confidence that your equipment is working as intended after delivery, that it is giving accurate results during testing, and that those results are repeatable should the test need to be revisited.
Your QA team will have confidence that the equipment is calibrated using traceable equipment, that users are trained and that the test protocols are approved, released and suitable for the latest ISO standards.
Consistent and repeatable test methods ensure reliable device performance and will greatly reduce the potential for user error. Devices being tested under fundamentally different test conditions due to ambiguous test plans is one of the most common mistakes we see, and often leads to costly repeat testing.
Understanding the performance of your system gives confidence in the accuracy of your results. We will test against the ISO 5840 standard to ensure compliance for flow, pressure and the drive output.
Have you modified your benchtop test system? Are you confident that the modification has not impacted the performance of the device? If a regulating body asks for justification behind a change, could you provide it? During this last step we will ensure that your system is accurate and any changes to accommodate stenting or unique mounting requirements have not compromised the validity of your data.
Understanding the impact system modification has on device performance can be a challenge for our customers – one which can be easily resolved through robust performance qualification.
While most quality management systems require these checks in some form, our third party qualification is an easy and inexpensive option which allows you the benefit of confidence while meeting that requirement. With confidence in your equipment, test plans and results, it is our hope that your regulatory path will be completed in less time and with fewer setbacks.
Please contact our support team (firstname.lastname@example.org) with any questions on qualification!