A mid-size pharmaceutical company was experiencing significant issues related to assignment of training items. Managers assigned training items to broad swaths of people, including external vendors and others who did not have an active role in the SOPs on which they were being trained. Newly-hired senior leaders were assigned several hundred training items, an unrealistic and demoralizing expectation to give someone joining a new company.
Implications of the Problem
Employees were assigned training items that were not relevant to their role, leading to a general mistrust of training and lack of training compliance.
Senior leaders were assigned hundreds of SOPs, many in which they had no direct responsibility, creating an inspection risk should they be asked to explain the processes to regulatory authorities.
Due to the excessive number of training items assigned, and the fact that employees did not trust that the training assigned would be relevant to them, training was often not completed in a timely manner or not completed at all, leaving the company vulnerable to inspection findings related to training compliance.
LSM was hired to create role-based assignments and curricula for the company’s entire library of training items, to assess and make recommendations for a streamlined curriculum assignment structure, and to develop a process to maintain and revise the content and curricula moving forward.
The LSM team worked closely with individual functional leaders to review individual SOPs and training items, make recommendations for changes to the content and curricula, and assist the LMS administrators in making required changes. We created a curriculum spreadsheet that included a current listing of revised and approved training by function, as well as a tab to capture audit history. The curriculum spreadsheet was printed, reviewed and signed by functional leaders on an annual basis. The signed and approved version was uploaded to the LMS for compliance and reference purposes. Our team also created SOPs related to curriculum development and administration, and created training materials for the organization on the new SOPs.
Impact of the Solution
As a result of the successful implementation of the LSM project, the company was able to achieve and maintain 100% training compliance across all functional areas. The company underwent an inspection of their training processes following project implementation, and passed with no minor or major findings.