2023 ASEE Annual Conference & Exposition

Quality management systems (QMS) are a collection of processes used in the medical device industry to describe the organizational structure, individual responsibilities, procedures, processes, and resources used to maintain quality (totality of features that determine fitness for use, including safety and efficacy). A key component of implementing QMS is using document controls to record and maintain all information relevant to the design, development, and manufacturing of a product. In a second year biomedical engineering design and manufacturing course, an assessment method which incorporates elements of QMS, document controls, and the Food and Drug Administration 510(k) submission process will be implemented. The primary motivation for this is to teach and reinforce document creation, management, and submission within the context of the medical device industry. The secondary objectives are to implement standards based grading and reduce instances of nonparticipation in group assignments. The tertiary objective is to improve student experience by allowing for learners to exert ownership over their classroom and project experience.

Like medical device manufacturers, students must begin by establishing their own Quality System. As part of the process, student teams of 3 to 4 individuals draft an organizational structure, create a system of unique identifiers for documents, and designate individuals with the task of reviewing and approving documents. On individual assignments students implement their naming and numbering conventions, track the status and revision number of the document, and conduct a peer review and approval of the document before submitting to the course management site. Once submitted, the document then undergoes an Acceptance Review and a Substantive Review led by the instructor or teaching assistant. The Acceptance Review looks for timely submission, completeness of the assignment, and adequate participation in team assignments. The Substantive Review is an assessment of the submission’s contents for correctness and/or concept mastery. In lieu of alphanumeric grades, students receive constructive feedback and notification of acceptance status. If a document was not accepted (submission did not meet the learning objectives), the students have the opportunity to redesign and resubmit. Resubmitting is thought to allow students to deepen their understanding of the course material while having first-hand experience of the QMS and document controls process. The standards based approach is hypothesized to have the benefit of normalizing mistakes, rewarding risk taking, and emphasizing iteration in design.

To test objectives of the QMS based assessment method, a survey instrument will be given to students pre and post course. It will also assess students’ attitude towards the grading method, perception of difficulty, motivation to continue design projects, preferred grading method, utility of feedback, teamwork, and understanding of FDA regulatory concepts.