Pharmaceutical Company Uses Competency-Based Learning

2022 Brandon Hall Silver Award, Excellence in Learning Best Advance in Competencies and Skill Development

A global pharmaceutical company with 11 industrial sites, five research and development sites, and 16,000 employees engaged Innovative Learning Group (ILG) to help its GMP Education Center of Excellence develop a competency-based learning (CBL) program for its Quality Control (QC) Analysts.

Situation

As with many pharmaceutical companies, Quality Control’s training centered around reading numerous, complex Standard Operating Procedures (SOPs) and participating in lengthy on-the-job training (OJT). In addition, analysts were trained on all knowledge and skills required to perform a test, even if they had learned these skills when trained on earlier tests. As a result, time to qualify to independently perform a single QC test exceeded five weeks.

Solution

A Quality Control CBL initiative was created to define the core and test-specific competencies needed to perform each QC test globally, and then to build the necessary learning solutions.

Competency Library and Profiles

The foundation of the Company’s CBL program is a competency library. To develop the division’s library, ILG conducted focus groups and interviews with model-performer analysts from Company sites across its network. Separate focus groups were conducted with the major functional areas within QC (e.g., Immunochemistry, Microbiology, Chemistry). The focus groups gathered data on the critical tasks, knowledge, and skills required to perform each test in each functional area. ILG captured this data in a Knowledge and Skills by Test matrix. Next, the ILG team mapped all knowledge and skills to competencies: competency definitions were either leveraged from the competency library created by the Specialty Care division of the Company or created from scratch based on the data in the Knowledge and Skills by Test matrix. The result was the Competency Library.

The Company’s Competency Library consists of all those core competencies and test-specific competencies needed by analysts. Competencies are defined at three learning levels in the CBL program: Foundational, Working Knowledge, and Application. For many competencies, the learner must achieve all three learning levels. Some competencies may need only the Foundational and/or Working Knowledge levels.

With the competencies defined, ILG then developed competency profiles for each QC test. A key characteristic of the Company’s CBL program is that the competency profiles are organized by test, not by role. The profiles identify the competencies required to perform the test and the learning levels that must be achieved.

Pilot Course Development

Initial delivery of the CBL program was a pilot at the company ‘ Toronto site. The pilot focused on training analysts on the ELISA test’s core and test-specific competencies.

The learning solutions created for a competency are a blend of e-learning (for Foundational and Working Knowledge levels) and redesigned OJTs (for Application). Conceptual content is the focus of the e-learnings. The OJTs then focus on building skills.

The CBL OJTs use the division’s Observe-Assist-Perform model of training, with some changes. In CBL, the Observe and Assist phases are eliminated when an analyst is learning a second test within the same test type; only Perform is required. In addition, each Step to Perform in the OJT includes why of the step, to reinforce proper performance.

CBL Global Implementation

While the pilot was being conducted and evaluated, global implementation of the CBL program was put into motion. The CBL solutions were translated into French, Spanish, and Chinese. The GMP Education Center of Excellence and ILG developed a curriculum-building tool to aid the sites in creating test-specific curricula in their training delivery platforms.

This tool, the Quality Control Competencies by Test Matrix, identifies for each QC test the competencies, competency profiles, and course information the sites will need to build their curricula. Further, a newly-created video walks site training personnel through the tool and how to use it.

Effectiveness Check

An effectiveness check (evaluation) was conducted at the Toronto site six months after the start of the pilot. The effectiveness check gathered data on four Key Performance Indicators (KPIs):

• Time to qualification
• Effectiveness of the content (the content enabled correct performance)
• Learner preparation for the OJT (how well-prepared analysts came to the OJT)
• Training validity (level of errors in testing after qualification)

To conduct the effectiveness check, ILG gathered both baseline (pre-CBL) and pilot (CBL) data from the learning management system, a survey, and interviews.

Results

The design of the CBL program has met the initiative’s and organization’s goals. Analysts are better prepared for the OJT and are qualified more quickly. The CBL program also delivers at least the same level of effective performance as under the old system.

Beyond quantitative results, the results also show that learners, trainers, and the learners managers all like the CBL program. Everyone can focus more on their core quality control testing responsibilities. In addition, since CBL is harmonized across sites, it is easier for analysts to transfer within and across sites. This helps analysts move along desired development paths, and managers are able to respond agilely to any changes to the testing workload.

The GMP Education Center of Excellence and ILG team continue to develop CBL solutions for the Quality Control audience. In addition, the pilot’s success has created interest in widening the use of CBL at the Company beyond Quality Control and perhaps beyond the division.

Go to Innovative Learning Group’s Medical Technology and Life Sciences page to learn more about the solutions we’ve provided to this exciting industry.

To learn more about how Innovative Learning Group can create custom learning solutions to help improve your business results, contact us at info@innovativeLG.com.