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

Ben Beliga

Second Advisor

Hiral Shah

Third Advisor

K. Buyanian

Keywords and Subject Headings

Risk Management, Software, Stature, FMEA, QMS


The ABC business unit within our corporation has no single, easy to use, risk management software platform. This has caused discrepancies between and within risk assessments and delays in regulatory approvals due to changes being requested by the notified bodies. It also led to numerous document formats existing in our Product Data Management system for the same types of documents. This costs the company time and money and was a burden on those responsible for creating and managing these assessments. The objective of this project was to implement a single risk management tool within the ABC business that would mitigate the majority of the issues with the current paradigm. This report details the tasks undertaken and the process by which a single risk management software platform was implemented in the ABC business. This project resulted in the creation of 2 risk assessment templates, 4 work instructions, 1 Form/Template, 4 Harm and Severity Libraries, and 1 Excel spreadsheet tool being rolled out to the organization. There were also numerous software validation documents involved. Initial feedback on the implementation has been positive.



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