Development of Site Quality Assurance & Compliance Near Miss Program

Abstract

The focus of this project is to create a Quality Assurance & Compliance (QAC) Near Miss program in a medical device company with the objective to reduce the number of 2023 near misses by 25%. A ranking system and tracking tool were created to log, track, and assess each near miss. In addition, the near miss program works in conjunction with the site’s inspection readiness program. At the culmination of the project the objective of reducing the 2023 Near Miss list by 25% was met by addressing/solving three of the eleven near misses. Both the ranking system and near miss tracking are within the same Excel tool, which will allow the site to continue to log, track, and assess near miss going into 2024. Key Terms ⎯ Audit, Inspection, Quality System, Near Miss.