Culminating Project Title
Date of Award
Culminating Project Type
Mechanical and Manufacturing Engineering
College of Science and Engineering
Creative Commons License
This work is licensed under a Creative Commons Attribution-Noncommercial-No Derivative Works 4.0 License.
Keywords and Subject Headings
Packaging FMEA Risk Process
A Twin Cities electronic device manufacturer, with its increasing customers in medical device industry, decided to get certified for ISO 13485:2003 and ISO 14971. As a result of this the company is implementing risk based approach to different process to fulfill the requirement of ISO 13485 and ISO 14971.This capstone project focuses on studying the packaging process and conducting risk analysis on this process. The project includes creating process flow chart, and calculating and managing risk using FMEA for packaging process. FMEA which stands for Failure mode and effect analysis is a proactive tool developed to identify, evaluate and prevent product and/or process failures. The project studies the packaging process and helps identifying different failure modes (FM) for each of the process input, determining effect of each of the FM, identifying causes for the FM, analyzing severity, quantifying occurrences and detectability to each of the FM, calculating risk priority number, assessing risk and mitigating risk according to Risk Management Plan for the company. This includes conducting risk-benefit analysis as well.
Ullah, ASM S., "Creation and Implementation of Process FMEA with Focus on Risk Reduction for Packaging Process" (2015). Culminating Projects in Mechanical and Manufacturing Engineering. 9.