How are IQ OQ PQ protocols applied to stand-alone ColorFlex EZ and MiniScan EZ instruments?

Here is how to think of IQ OQ PQ being applied in general for all HunterLab instruments.IQ Instrument Qualification defines a protocol by which an instrument is set up; software installed as needed and both hardware and software/firmware elements verified as working correctly by completing a successful instrument standardization.

OQOperation Qualification defines a protocol in which the sensor diagnostics tests are run and shown to PASS to verify that the instrument is operating correctly to manufacturer’s tolerances.

PQPerformance Qualification defines measurement protocols for each of the customer’s sample types based on best practices that ensure a repeatable measurement.

For the stand-alone ColorFlex EZ or MiniScan EZ, IQ OQ PQ breaks down this way.

On these instruments, firmware is pre-installed on the stand-alone sensor instead of software. To verify IQ, power up the CFEZ or MSEZ; activate the Main Menu and successfully standardize the instrument using the black and calibrated white tile. Installation Qualification is complete if the instrument can be successfully standardized.

For OQ, run Main Menu/Diagnostics. If the instrument successfully PASSES both the Short Term Repeatability diagnostic test on the white tile and Long Term Repeatability diagnostic test on the Green Tile, the instrument is considered to be working correctly within manufacturer’s guidelines. The operational qualification has been met.

PQ or performance qualification is based on ensuring a repeatable measurement on customer samples. Given the many types of samples were color is measured, the best methodology and accessories may require guidance from a HunterLab representative. However, once the measurement method has been established, the goal is to verify that the sample can be repeatability measured several times using a single operator and instrument. If the sample can be measurement repeatably, performance qualification has been met.

 

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