Can You Detect Me Now?
by George Sweeney
Is risk acceptable? It is a simple Yes or No.
EP 23-A lists these Potential Failure Modes:
- reagent deterioration during shipment
- calibration deterioration
- sample data entry error
- low-value sample
- clots from the sample
- sample carryover
- fault caused by maintenance
- use of expired reagents
- use of deteriorated reagents
- spectrophotometric drift
- operator changing measuring system settings
- power fluctuations
Can you detect all of these failure modes? Some?
- How much would any of these affect your patient results if they go unnoticed?
- What effect would the deterioration of the calibrator have on patient results?
- Would your Quality System detect changes indicating any of the above?
As long as your controls are stable and they perform with a predictable distribution that mirrors that of the patients, you will be able to detect when you need to check to see what is happening and when you will need to stop in order to prevent potentially erroneous results from going out.
What is the risk of failure to detect failures? A human’s health and life.