Calvin London (clondon@celgene.com) is the head of Business Operations and Integrity for Celgene Pty Ltd. in Australia and New Zealand.
Training is an important part of any compliance program but often one of the most difficult areas to do well. Like several other areas of compliance, training has become heavily reliant on the use of electronic systems. These systems effectively continue to deploy a training assignment of a policy or standard operating procedure (SOP) until—with the click of a button and an electronic signature—the assignment is completed.
Efficient? Absolutely. Effective? Maybe. The problem with this type of training modality is that it puts the responsibility on the employee to “do the right thing.”
The complexities of read-and-understand training that forms the basis of most electronic deployment systems have been previously discussed.[1] Even the most diligent and compliant employee will be placed into a situation where it is just easier to say, “Yes, I understand it, or if not, I will come back to it,” sign it off, and then move on. Added to this is the dilemma that even if an employee reads and understands a process or procedure at the time of the training, will they remember the process in a week’s or a month’s time, especially if they use the process infrequently?
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.
