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.
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:
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.
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.
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