What are the current trends and challenges in data error and deviation management in GMP?

The potential for a deviation exists if the primary data errors (i.e., Inadvertent inattentiveness, Misinterpretation of training and lack of training, Fatigue, Overloading, Repetitive tasks) or secondary data errors (Lack of targeted documentation and processes, Duplicate documentation, Lack of robust training, and Environmental distractions) affects the quality of the information recorded significantly. To maintain a good working force a company must have: targeted procedures, continuous training programs, a robust company culture, and consideration of the overall operator's working environment, mental and physical health.

In my opnion, the way data error is described here it cannot be differentiated with deviation. When data errors occur, the operator is deviating from instructions in GMP documentation or from how the training has been proviuded.

I am inclined to disagree with @RamadasBhat that "data error" and "deviation" are not differentiable. A transposition error or transcription error meets the definition of a "data error" and is not necessarily the result of either deviating from SOP or insufficient training. In other words, the root cause for a data error is not necessarily "deviation from SOP" or "insufficient training".

The basic question with every data error is wrong practices of data collection and analysis. The other problems are cooked up investigation to evade the deep dives by auditors. The improper deviation investigation always leads to unnecessary deviations of similar nature throughout the process and wastage of manpower and time investment leading to unproductive outcomes.

One of my trainers once said to the class that in the pharmaceutical industry “We produce both medications and large amounts of data”. In my experience data integrity and compliance are improved when the operator has sufficient procedures in place, support, oversight, training, and a culture of keeping calm under stress with appropriate guidance. Manufacturing always is running against timelines, but sufficient time needs to be allowed for quality of a process to succeed, including data integrity and compliance.

One of the biggest mistakes that a company can do is to fall behind in operators training. Educative experiences can happen anywhere at any time. A supervisor can read the deviations that occur during that day and discuss them with their operators. Open discussion always improves performance. Training should be a continuous conversation. Also, paying attention to who needs more advice than others. Reading SOPs alone or watching videos does not cut it, active learning needs to happen in the floor in the day to day.

Hi. AlsoImportant to note,SOPs need to be clear &concise.Ensure they contain all relevant information to successfully perform the task/job.Create Work Instructions,with pictures and diagrams,if needed &perform periodic reviews of procedures &timely updates of procedures to include important new information.Ask the end-users &all personnel involved in the process if the instructions are clear,where they can be improved&immediately submit the changes.Simply stating “re-training“ as a “corrective action” is not an acceptable response without an analysis or change/improvement to the process because that is only checking a box and simply puts the blame back on the operator,(and will likely happen again).Effective checks & audits are essential.

The least of these not being "sharing of best practices". This simply cannot be overvalued as a critical component of bringing measurable success to your data error and deviation management metrics. "Empowering the shop floor" (as I refer to it as) is the single, most impactful strategy you can implement with little to no cost and hugely measurable results in the form of effectiveness checks. When your team is trained on how to identify, and equipped with the confidence of a culture that supports reporting deviations, your continuous improvement learning curve accelerates.

I agree with these statements. I want to emphasize the fourth point here continuous feedback of how to improve a procedure should be the norm. Operators should not be afraid to speak up or to get reprimanded for voicing their opinion, and if they commit a data error that leads to a deviation, the training should be robust enough to help the operator improve.

It’s so important to have a quick & easy way to trend data, (i.e. deviations of related processes, & searching repeat deviations/CAPAs). Not having a system that enables that can be very frustrating and open up to reg. audit findings.

One trend that I’ve seen in determining deviation root cause is the tendency to assign it to human error. While human error can play a role in the deviation, it is important to dig deeper and utilize the appropriate root cause analysis tool to identify whether there is a systemic issue with your Quality System(s) (I.e. training, procedures, etc.). By identifying the correct root cause it will improve the effectiveness of the corrective action that is implemented.