A medium-sized pharma company delivered most of their SOPs to employees with Read and Understand training expectations. As a result, managers questioned whether employees fully comprehended some of the critical, especially strategic, issues for which they were responsible. These managers reported concern about the team’s low sense of urgency regarding preparation for an expected upcoming FDA inspection. They described a number of other similar instances of a lack of focus or orientation toward critical areas of compliance in the business.
Implications of the Problem
Managers felt that the teams were not prepared for the operational expectations of how an inspection would need to be conducted, when the time came.
Team members weren’t fully aware of their responsibilities to perform specific information archiving tasks.
Members of the Quality team spent extensive time giving guidance on specific areas of work, where SOPs should have been able to give the same guidance.
LSM was asked to help design a solution for this extensive, murky issue. Our team interviewed members of the client’s management team and conducted an assessment of the SOPs relating to the issues described.
Based upon the information gathered, LSM worked with the management team on recommendations to develop a number of top priority “enhanced e-learnings.” These included modules on Inspection Readiness, CAPAs and Deviations, Risk Management Protocols, External Vendor Oversight, and an FDA Regulations Overview.
Based on the specific topics, the audience, and the content matter, LSM created some short videos for broad distribution and some professional animated shorts, as well as more traditional interactive e-learnings with exercises and full assessments. We incorporated these training items into the company’s LMS, as appropriate.
Additionally, our team designed and facilitated leadership training specifically for the company’s Quality leadership team for the purpose of strengthening their management skillset so they could empower employees to utilize the tools at their disposal rather than constantly emailing Quality for quick answers.
Impact of the Solution
As a result of our work with this mid-sized pharma company, training on specific topics were clearer, more actionable and easier to understand. In addition to the required SOPs, all team members were able to use supplemental, high-level training materials to support their understanding of and ability to execute critical processes within the company. Understanding and retention of information improved, and the Quality team’s burden was reduced regarding the need to repeatedly explain critical concepts on an ad hoc basis.
Based on survey results, the overall opinion of training improved, which ultimately drove training compliance and an inspection-ready organization. Several months after we implemented our training programs, the organization underwent an unplanned FDA inspection. The company was prepared for the inspection and received no findings related to topics on which employees trained with materials developed and implemented by LSM.