Presentation
Onboarding in the Life Sciences Industry: How Much Training is Too Much?
DescriptionThe purpose of this research was to characterize the process of onboarding in the life sciences industry. Workers in the Life Sciences industry are required by regulatory action in the United States, as well as the EU to be qualified to perform their jobs by “education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions (Code of Federal Regulations - § 211.25(a))”. College and even graduate education do not often include the exact skills needed to manufacture a company’s specific drug or device, many of which are proprietary, and even generic medicines and devices have specific formulations and configurations such that companies need to train their employees for them to be qualified to do their work. New employees often complain about the volume of training material, and the small amount of time given to process the information. Evidence from our prior work showed that more than 70% of that training comes in the form of Standard Operating Procedure documents (SOPs), and that about 54% of those documents are being reviewed for less that two minutes. However, there is little data to characterize the volume of training items (be they instructor led courses, SOPs, learning assessments, or offline activities, like practicing a task or performing the task in front of a qualified trainer (that the trainer must be qualified is also a matter of regulation). To investigate and characterize the on-boarding burden of the typical life sciences worker, we examined data from UL Solutions ComplianceWire, which is a learning management system (LMS) used primarily in the pharmaceutical and medical device industries. At the time of this writing, ComplianceWire has an active user base of approximately 1 million users in 130 countries and over 720 million training events to examine. For this study, a subset of data was selected, consisting of 98,582 newly created users starting January 1, 2022, through December 31, 2023. The number of training items assigned, and the number of training items completed in the first 6 months of the employee life cycle were tabulated. Average numbers of assignments and completions will be presented and are summarized here with the notation Mean (Standard Deviation). The overall mean number of items assigned was 10.004 (34.69). You can see the standard deviation was much higher than the mean, and the distribution was severely skewed right. In fact, using a standard definition of an outlier (1.5 times the interquartile range), there were a total of 13,537 total outliers! The minimum number of training items required was 1, but the maximum was 1279. Just considering that there are 2000 hours in a typical work it is hard to imagine that particular employee accomplishing anything but training. A scatterplot of the data suggested that most employees were way behind on their training. The average person in this sample is assigned 10.01 (34.68) training items, and only completes 3.2 (7.16). This is a huge compliance and business risk for the companies, and a societal risk for patient safety.
Subsequent analysis looked at the same data by industry type (Pharmaceuticals, Medical Devices, and Other). The category Other in this case included for example, government, consumer products, health insurers, and food. In addition, individual company titles and job functions were categorized, and a subset of the data analyzed the assignments and completions by job title and job function.
The data were segmented by Medical Device (23% of sample), Pharmaceutical (58% of sample), and Other (also 19%). Overall, the medical device participants had the largest number of training items assigned on average, 11.38 vs. 9.86 for Pharma, and 3.05 for Other industries. Pharmaceutical and medical device products can be complex, so we would expect the requirements to be greater for general industry.
A further subset of the data were examined to look at training requirements by title and function. Because job titles are not standardized across the sample companies, natural language processing was used to identify the data fields most closely related to job title. We were able to assign standardized job titles for 33,030 cases, and job functions for 24,239 cases. Reviewing the data for job title it was clear that associates were assigned the largest number of training items 11.4 (38.5) compared to for example contractors, who were assigned only 6.7 ((11.1) training items. It may be appropriate for contractors to receive less training than employees, but those contractors might also be performing critical tasks relevant to patient safety, so hopefully training programs for contractors were also complete and appropriate to the tasks they performed.
Looking at the data by function (e.g. manufacturing, vs. clinical, vs quality control, etc.) clinical researchers bore the brunt of this onslaught of training, averaging 24.6 (44.1) training items. Manufacturing associates were ranked number 3 on this measure, being assigned on average 16.2 (58.2) items but you can see that the standard deviations are quite high. Also, in either case the number of training items completed is much lower, the completion numbers for clinical were 2 (2.4) and 4.1 (6.2) for manufacturing. Again, the data are pointing to compliance risk, business risk, and patient safety risk. If life sciences folks are routinely this far behind not their training, you can ask if we are really structuring these programs correctly.
A more complete set of data based on the 17 different function and 9 job titles will be presented at the conference. Recommended strategies for training employees more effectively will be provided. We will also present a case study of a pharmaceutical company, that just by re-arranging their onboarding sequence, was able to improve onboarding time by 25%, and reduce scrap rates by 30%.
Subsequent analysis looked at the same data by industry type (Pharmaceuticals, Medical Devices, and Other). The category Other in this case included for example, government, consumer products, health insurers, and food. In addition, individual company titles and job functions were categorized, and a subset of the data analyzed the assignments and completions by job title and job function.
The data were segmented by Medical Device (23% of sample), Pharmaceutical (58% of sample), and Other (also 19%). Overall, the medical device participants had the largest number of training items assigned on average, 11.38 vs. 9.86 for Pharma, and 3.05 for Other industries. Pharmaceutical and medical device products can be complex, so we would expect the requirements to be greater for general industry.
A further subset of the data were examined to look at training requirements by title and function. Because job titles are not standardized across the sample companies, natural language processing was used to identify the data fields most closely related to job title. We were able to assign standardized job titles for 33,030 cases, and job functions for 24,239 cases. Reviewing the data for job title it was clear that associates were assigned the largest number of training items 11.4 (38.5) compared to for example contractors, who were assigned only 6.7 ((11.1) training items. It may be appropriate for contractors to receive less training than employees, but those contractors might also be performing critical tasks relevant to patient safety, so hopefully training programs for contractors were also complete and appropriate to the tasks they performed.
Looking at the data by function (e.g. manufacturing, vs. clinical, vs quality control, etc.) clinical researchers bore the brunt of this onslaught of training, averaging 24.6 (44.1) training items. Manufacturing associates were ranked number 3 on this measure, being assigned on average 16.2 (58.2) items but you can see that the standard deviations are quite high. Also, in either case the number of training items completed is much lower, the completion numbers for clinical were 2 (2.4) and 4.1 (6.2) for manufacturing. Again, the data are pointing to compliance risk, business risk, and patient safety risk. If life sciences folks are routinely this far behind not their training, you can ask if we are really structuring these programs correctly.
A more complete set of data based on the 17 different function and 9 job titles will be presented at the conference. Recommended strategies for training employees more effectively will be provided. We will also present a case study of a pharmaceutical company, that just by re-arranging their onboarding sequence, was able to improve onboarding time by 25%, and reduce scrap rates by 30%.
Event Type
Oral Presentations
TimeMonday, March 314:10pm - 4:30pm EDT
LocationPier 9
Simulation and Education (SE)