We observed one error during review of batch manufacturing record that production officer skips to record the one in process test during compression stage. After investigation we got root cause it’s happening due to over sight by offer. So what’s CAPA should be taken to avoid such event again. It’s second time happened, first time we had given training concern person and informative training regarding to same had given to all personal working on shop floor . So plz suggest me effective CAPA for this.
You can also improve/upgrade your system or equipment for easy to excess/work without any human error and same can be treat as a CAPA.
Example: In granulation process- online batch record which is generated by SCADA/PLC can be attached as part of BMR moreover if we are missing to attach this record it does not have impact on the process parameter because it is always store in your system and any one can refer from SCADA.
There is lot of instruments coming in market with 21 CFR part 11 complying but human error can happened at any stage. For example, during setting of program it’s choose wrong program or skip to select one of the parameter which should be selected. My question is for that yes, that person made mistake to select one of the option for in process testing. We filled deviation, going through ingestion now it’s term to given effective CAPA for that… so what can we do to avoid such type of events again?
@JaredCroft provided a potential solution but you need to bear in mind that a CAPA is a process, not a solution. You indicated that in your initial CAPA work, you concluded that human error (oversight) was the root cause. While possible, the true root cause is typically something else. And your corrective action (training) was clearly not effective.
The process to identify the true root causes is difficult and takes an individual well-trained in problem solving / root cause analysis.
Have you talked to the individuals that are required to complete the record? They are in the best position to offer solutions (and if it’s their suggestion, they generally take ownership).