Quality/Regulatory Support – Case 1

Industry: Medical Device
The Need

An international medical device company needed to create new policies, procedures, and controls for its quality system. They needed to get this new information out to field engineers and field sales staff that would access it remotely. Unfortunately, the field engineers and field sales staff didn’t think the quality system was aligned with their real work. They thought it was cumbersome. The company wanted these employees to realize that following the Quality System policies, procedures, and controls was actually the normal way to work.

Solution

Dashe & Thomson created communication and training plans to help the employees understand the need to change how they worked with the quality system.

  • Our communication plan focused on explaining why the change was necessary. It stressed the importance of the employees hearing from the senior executives in the company and the employees’ immediate managers about the importance of the quality system.
  • Our training plan identified the new behaviors that the company desired in its employees and ensured that the training engaged these learners as active acquirers of knowledge. It incorporated feedback mechanisms to check comprehension and established mechanisms to check for new behaviors back on the job.

To address the need to motivate employees through higher level management, we created a video featuring the senior executives and a celebrity speaker known for his work with quality systems, and presented it at the annual sales meeting. To address the need for remote training and training outside of business hours, we delivered training at sales meetings, on DVDs, and on the field portal of an internal website with links to the company’s learning management system (LMS).

Results

Because of the high profile of the project, the focus on motivation, and the excitement generated, the employees were able to work with the new policies, procedures, and controls created for the quality system. They were able to ask themselves how they knew they were taking the right action based on the quality system and how they knew where to go to access and confirm their understanding of the new policies and procedures.