The Repository @ St. Cloud State

Open Access Knowledge and Scholarship

Date of Award


Culminating Project Type

Starred Paper

Degree Name

Engineering: M.E.M


Mechanical and Manufacturing Engineering


College of Science and Engineering

First Advisor

Hiral Shah

Second Advisor

Ben Baliga

Third Advisor

Balasubramanian Kasi

Creative Commons License

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.


I have taken efforts in this project. However, it would not have been possible without the kind support and help of many individuals. I would like to extend my sincere thanks to all of them.

I am highly indebted to the chair and committee members of the capstone project for their guidance and constant supervision as well as for providing me with feedback regarding the project and also for their support in completing the project.

I would like to express my gratitude towards my mother, wife, and fellow co-workers for their kind co-operation and encouragement which helped me in completion of this project.



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