Conveniently Forgetful

Our procedure mandates that stability monitoring data for each of our 18 chambers be reviewed (two probes in each). The point is to confirm that no undetected excursions occurred and to possibly identify unusual activity. It probably takes our experienced technician about 4 hours per week to print the charts, review them and document that review in the maintenance log—granted, a tedious boring task. We do have a caveat in the procedure that in the event of a missed review it can be performed ASAP and as long as there was no impact (no delayed detection of an excursion), the delay can simply be noted and approved by me, the stability manager.

Unfortunately, the technician takes frequent advantage of this caveat—probably at least once a month. The reasons given are his being OOO or called to handle other chamber priorities and sometimes just forgetting. We’ve had one case that did result in delayed detection of an excursion, and that was investigated with CAPA that was clearly not effective. I’m close to making this an HR issue, but first I’m looking to understand what kind of compliance risk is developing. I’m also looking for input on how it can be made less of an odious task.

Ouch. First, now that there is a formal ineffective CAPA out there for an inspector to find you really do have a compliance risk that necessitates stronger action. As such, you do need to make this an HR issue, but I’d encourage you to meet this technician halfway with significant process changes to simplify this task. Why not one single summary of all charts and noting an individual chart only if an anomaly is detected? Also, can the charts be viewed onscreen and could the frequency be changed to monthly?