I Stuck my Hand in the Stopper Bowl

October 12, 2017 11:32 am || || Categorized in:

A tale of why read and acknowledge is a failed method of operator training.

BioPharm -14

The operators working on the filling isolator were working 12-hour swing shifts.  They had to cover a 24-7 schedule with people from two regular 8-hour shifts. According to the company’s Learning Management System, all of those operators were up to date on their training and were qualified to be performing the job tasks assigned to them that night.


Sometime around 2:00 am, one operator was tasked to add more stoppers to the stopper hopper through the designated Rapid Transfer Port in the isolator. The operator attached the pre-sterilized stopper bag to the designated port and reached in through the isolator gloves to open the port door. The operator opened the door using the appropriate intervention technique and the stoppers began to dump into the stopper hopper. However, the operator noticed that the stoppers dumped only on one side of the stopper hopper so they reached into the hopper to spread the stoppers around. The filling supervisor noticed the operator’s hand inside the hopper and stopped filling immediately. A full investigation ensued, site leads were woken up in the middle of the night, and the rest of the operators had several hours of downtime before they could continue work.


In regulated industry where companies must prove their employees are adequately trained to perform their job function, many pharmaceutical manufacturers rely on the “Read and Acknowledge” method for the bulk of their operator training. Training departments assign lists of Standard Operating Procedures (SOPs) to operators and the operators are expected to read the procedure and sign off that they not only read it but that they understand the material. In the case just described, this company decided “Aseptic Technique” and “Stopper Addition to the Isolator” should be simple “Read and Acknowledge” training items. In fact, the operator’s only training on how to handle items aseptically (particularly the stoppers) was accomplished by self-directed reading.


There are more effective methods for training operators on high-risk tasks. Learners can watch the task being performed via computer-based training, video, or observing an instructor demonstrate the task. Learners can try the task with hands-on guided practice in a simulated environment. Learners can prove competence through a rigorous on-the-job training or qualification program.


All of the more rigorous forms of training listed do require a greater initial investment. But this investment might have prevented the operator from reaching into the stopper hopper in the first place. In this case, the investigation results concluded that training was to blame, and the corrective action required the entire operations staff to re-read the “Aseptic Technique” SOP prior to returning to work. The total time lost to this one incident was over 100 man hours, not to mention a 10-hour delay before manufacturing could recommence.  In the end, this company failed to recognize the real root cause – that they did not have an appropriate organizational system in place to reduce the likelihood of operator error.


Like any risk encountered during the manufacturing process, the risk of human error can be reduced through appropriate controls. Commissioning Agents’ Human Performance Services can help advise, plan, and implement changes at your facility to increase efficiency and reduce human error.


Commissioning Agents has the breadth of technical industry experience paired with deep knowledge of training and instructional design that can help you take your staff qualification program from perfunctory to intentional. Contact us by clicking the button below!