Solution to Calibration Failure of Liquid Chromatography

[Tattukolla]

Hi all,
happy to share this incident .

Topic is HPLC Calibration:
While running Calibration of LC wavelength accuracy has been failed at minimal absorbance with caffeine.We found that it happen because of out let ball valve of pump in Agilent 1260 infinity model.
My user raised the breakdown request to service engineer as "Wavelength accuracy failed".
At the same time we addressed the same through incident.
Service engineer replaced the out let ball valve with new one .And carried out the calibration by doing Flow test as it required for any ball valve changing.

1.What is the CAPA?
2.Is prevention is required where we proposed only corrective action?
3. Is it required to reanalyze the previously approved batches on same system, and our SOP says to reanalyze three batches on other instrument.
4.0 Any root to not analyse those three batches?
Regards

SATYA

[v9991]

actually your problem-description seems to require further more details...(probably updates - clarifications ...)
here's an quick attempt to provide some thoughts which could correct/clarify your approach...

1. RCA confirmation/clarification :- Try & understand how an “outlet ball valve of pump” is related with the wave-accuracy? (how is flow variation related to wavelength accuracy; as an outsider to the problem, I would have suspected something like, detector, flow thru cell, working standard purity etc.,)

2. INVESTIGATION scope:- Should include the assessment on impact on previous batches; (ascertaining the time&point of impact …from when this problem has been affecting the results/data if any)

3. CORRECTION :- (again, how is it adequate to establish the flow clabiration? even going by your assessment, we must have established the wavelength accuracy as well...right?) anyways, it should suitably addressing the above RCAs and re-establishing the equipment calibrated-status

4. CORRECTIVE ACTION :- addressing the points evaluated during investigation phase, impact on other batches, or disposition of current analysis etc.,

5. PREVENTIVE ACTION (to ensure that problem is not recurred; or atleast finding out the symptons and problems as and when they occur…not waiting for calibration frequency ):- improving the monitoring mechanism viz.,
for a pump, daily monitoring of ensuring the priming, valve-washing etc.;
if it’s a detector, then daily monitoring of noise levels, proper washing/solvents at end of each analysis/ at the end of day.
if its found to be due to particular method...then look at suitable evaluation of procedure of finalizing all current and future methods method...

...
hope that it helps.