CEP Magazine - September 2019

Trend monitoring shows the need for change

Over the past couple of years, we have been trying some alternate training modalities to educate and train employees. A more structured training process that addresses the underlying principles of how to use the knowledge seemed a better option than repeated reading of a procedure. This has been called “training in the moment.”

In our organization (a country affiliate of a larger multinational company), we diligently monitor deviations from documented processes or procedures. We noticed over a three-year period that there was steady increase in the number of reported deviations/excursions. In our system, deviations relate to Good Distribution Practice (GDP) associated with the supply of commercial product; excursions relate to variations from established compliance with a documented procedure.

In 2017, there was a 71% increase in the number of reported deviations/excursions from 2016 (89 compared with 52). In some respect, this was self-inflicted as, in this year, we commenced a program mid-year to encourage employees to speak up if they saw potential compliance issues.^[2] Even making allowances for this, it was unacceptable. The other key performance index that we use—time to resolve the deviation/excursion—by contrast, showed an 8% decline over the same period. In response, we implemented repeat read-and-understand training deployed through an electronic portal for all employees in the deviation/excursion process.

A year later, the trends again showed a 42% increase: 126 deviations/excursions compared with 89 in the previous year. As seen previously, the time to process the deviations/excursions dropped by a further 15%. Although there were also some extenuating circumstances, such as an increase in the deviations associated with third parties not directly in our control, the trend was alarming and indicated that our repeat read-and-understand training had little effect on improving performance.

Causes and solutions

A deeper investigation into the trend revealed two important issues. The first was that, in general, employees did not have a good understanding of what was required to create a deviation, process it, and arrive at corrective and preventive actions. For them it was an event that someone else handled, even though they may have been the cause in the first instance. This was despite the additional training events that had occurred in 2018.

The second issue was that there was a lack of understanding related to the work involved in processing the deviations/excursions, much of which was retrospective and counterproductive in terms of effective utilization of the workforce. Furthermore, most of the deviations/excursions were being handled for employees by the quality and compliance team in the interest of expediency and on the basis that it was easier to do the work themselves, rather than re-educate the employees responsible for the initial issue. (Who said compliance was not helpful?)

It seemed that the issues we could not address through the read-and-understand training were focused around the appreciation that it was the responsibility of the owner of the deviation/excursion to prepare the initial draft for review and approval by compliance. The difference between increasing numbers versus improved efficiency in processing deviations could also be explained, because the latter was being performed by compliance, who were efficient in the deviation process.

We changed our mode of training and created a module specifically for face-to-face training on the deviation/excursion process. This culminated in participants having to prepare an actual deviation on a specified topic, selected or modeled on a real-life scenario. Participants were asked to work though their assigned scenario as if it were an excursion, using the SOP as guidance. For example: “During reconciliation for expenses, there is an entry for $300 to pay a healthcare professional to speak at one of our internal meetings. You try to find the paperwork to attach as supporting documentation, but you soon realize that it was incorrectly paid without the full documentation.”

Evidence of a positive impact

Year-to-date numbers for deviations/excursions have already declined; 48% less than the number processed in the time frame comparable to 2018 and 23% less than the same period in 2017. The average time to complete these remains comparable, but the time investment by the compliance team has been significantly reduced—almost halved.

When employees (N=15) from the training sessions were surveyed to determine if this form of training was (a) more acceptable and (b) more effective than the alternative read-and-understand training, 90% agreed. Eighty-five percent indicated that they benefitted from the practical approach of providing the example to work through, and 90% indicated that they would recommend this training to colleagues.

We have also found this method of “hands-on” I-do-and-I-remember training was successful for training employees in areas such as technical writing, where skills to create SOPs, protocols, or other process-related documents are required. A similar format to that described above was used, but the topics that participants were asked to create were much simpler, more personal, and reflected everyday life (e.g., making a cup of coffee, getting dressed, or going shopping). These may seem like very simple tasks, but when you consider the requirements, order of events, and other nuances, they provide fun examples with a useful message.

The time investment in preparing and executing face-to-face training is clearly greater than deployment through an electronic portal. This example shows, however, that there is considerable benefit to in-the-moment training modalities, such as actually getting key stakeholders to perform tasks for enhanced learning and superior understanding and retention of information. When combined with an effective risk assessment of who needs the training, the benefits will outweigh the investment.

This example also demonstrates how the different aspects of the compliance program—monitoring and trending, risk analysis, and effective training—can combine to make a compliance program not only effective but also efficient. Taking a different approach from the training norm had significant effects. Change is good, especially when you control it!

I would like to acknowledge the contributions of Reyna Bartell, Senior Compliance Liaison, and An Nguyen, Senior Quality Liaison, for their technical contributions associated with the training module design and execution.

Takeaways

• Read-and-understand training puts the responsibility on the employee to do the right thing.

• A structured training process that addresses the underlying principles of how to apply one’s knowledge is a better option than repeated reading of a procedure.

• Face-to-face, hands-on training has proven more successful in reducing source errors than read-and-understand training.

• Considerable benefit from in-the-moment training modalities can be realized by getting key stakeholders to perform tasks for enhanced learning and superior understanding.

• When different components of a compliance program combine—monitoring and trending, risk assessment, and training—it results in effectiveness and efficiency.