International Project Management Day




System Hazard Analysis Method


Quick Summary
Medical products are required to perform risk management in compliance with ISO 14971:2007. This template provides a document outline based on that standard that your team can fill out and use as their official System Hazard Analysis document.


This template requires a Premium Subscription
Please log in. Don't have a log-in? Sign up now. Already a Member? Log in to upgrade immediately and get the file! A Premium subscription is only $14.95/month or $149/year and gets you over 200 templates, guidelines, and checklists.
15-day free trial period for new Premium subscribers! Learn more
Log in to download this file

Username:  
Password:  

What this is

This file contains an ISO 14971:2007-based document outline that can be used to guide and document a System Hazard Analysis on a medical product. Medical products are required to perform risk management in compliance with ISO 14971:2007. This template can be filled out by the team and becomes the System Hazard Analysis document. It lays out the definitions and key concepts, an overview of the process, and description of each step. In addition, it presents an example of a probability, severity and risk level scoring system, consistent with our related template, the Medical Product Risk Management Process Guideline.


Why it's useful

System Hazard Analysis is required for medical products by U.S. and other international regulatory agencies. The SHA focuses on identifying potential hazards associated with the use of a product, estimating and evaluating the risks, controlling the risks, and monitoring the effectiveness of the controls.

This template is one of the first methods that a team can use to assess risk on such a project. It can be used relatively early in a top-down fashion, before the design is fully formed. In fact, it's best if this precedes detailed design since many of the identified hazards will need to be mitigated by the design.


How to use it

Initially, your company should make any needed changes in the template and adopt it as part of the quality system. Make sure the scoring system is agreed to, especially with the Regulatory function.

During the early Concept phase, the project manager should pull the team together to begin the process of System Hazard Analysis according to the method laid out in this template. It is very helpful to teach the team the process before beginning to use it. Having a medical professional take part is also extremely crucial.

During the Concept phase, initial high-level risk assessment:

  • Start by following the risk management process, then use the system hazard analysis method to conduct the analysis.
  • Fill in the table in section 6, first assuming NO mitigations; then identify mitigations and reassess the mitigated risk.
  • Use previous experience with similar products, expert opinions on relevant technologies, and brainstorming with a cross-functional group.
  • The system hazard analysis should be reviewed and updated when major design changes are contemplated or when more detailed methods uncover a hazard.

As the design proceeds, other methods—such as FMEA, FMECA, and FTA—may be appropriate. Eventually the team will use bottom-up methods as the design gels and becomes analyzable. Risk assessment will occur in more detail as the potential implementations are designed and planned. All risks can then be further evaluated to understand their potential impact on user or patient safety. Appendices A and B of this template provide possible contributing factors and questions that may spur further discussion of potential hazards as the project proceeds.



About the Author

Matt Glei is Managing Partner of Know-how Consulting in Honolulu, Hawaii. This consultancy provides performance coaching in areas such as collaboration, knowledge management, intellectual property, virtual teams, as well as program, project and risk management. Matt also has long experience in product development, managing project portfolios and strategic planning.

Matt has spent his 30-year career in high technology and medical product development and operations, managing at companies such as Hewlett-Packard, Nellcor, and Hoana Medical. His background includes significant periods in Research & Development, Operations as well as Marketing. His career includes five-person start-ups, all the way to 350 M$ high-volume businesses with thousands of employees. As different as these company situations appear, the fundamental performance problems remain the same.

Matt is one of the co-founders of ProjectConnections.com.


This template requires a Premium Subscription
Please log in. Don't have a log-in? Sign up now. Already a Member? Log in to upgrade immediately and get the file! A Premium subscription is only $14.95/month or $149/year and gets you over 200 templates, guidelines, and checklists.
15-day free trial period for new Premium subscribers! Learn more
Log in to download this file

Username:  
Password:  





Related Templates
Medical Product Risk Management Process
A model for medical product risk management based on ISO 14971:2007 requirements, including tables and rationales for a risk scoring system, checklists, and more.




©Copyright 2000-2017 Emprend, Inc. All Rights Reserved.
About us   Site Map   View current sponsorship opportunities (PDF)
Contact us for more information or e-mail info@projectconnections.com
Terms of Service and Privacy Policy

Get Our Newsletter
Get our latest content delivered to your inbox, every other week. New case studies, articles, templates, online courses, and more. Check out our Newsletter Archive for past issues.

Follow Us!
Linked In Facebook Twitter RSS Feeds

Got a Question?
Drop us an email or call us toll free:
888-722-5235
Learn more about ProjectConnections, our contributors, and our membership levels and product options.