Risk Analysis

Description

Standard operating procedure describing how to analyze risk for products manufactured at the firm.  This document is more directed towards medical device manufacturers, but can be tailored for any type of product with inherent risks.

Included in the document are an example of an FMECA Table and a Fault Risk Tree Graphical Analysis.  Here is the purpose from the document:

Products and/or processes provided to customers by Company Name have inherent hazard associated with their use.  The purpose of this document is to:

• Identify the product or process, its usage, and issues surrounding potential hazards.
• Identify current and potential hazards associated with the use of the product or process.
• Assess risk potential of failures due to the identified hazards.
• Two techniques are presented here; Failure Mode, Effects, and Criticality Analysis and Fault Tree Analysis.
• Mitigate hazards which exceed the threshold of acceptable risk.