Based on ISO 14971:2007 requirements, provides a model for medical product risk management processes, and an overview of what scrupulous risk management looks like in safety-critical environments. Includes risk-scoring systems and rationales, checklists, and more.
What this is
This file contains an ISO 14971:2007-based process that serves two purposes: it provides an overview of what constitutes an acceptable approach to product risk management in the medical industry; and it provides a template for the process document a medical company must include in their quality plan to pass these FDA and ISO requirements. It lays out the definitions and key concepts, an overview of the process, and a description of each step. In addition, it presents an example of a probability, severity, and risk level scoring system, along with a rationale behind the scoring system.
Product Risk Management is focused 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. Although the methodology is philosophically similar to project risk management, the rigor and focus on safety for the user are significantly different. Medical products are required to perform risk management in compliance with ISO 14971:2007 (an FDA-recognized standard). This international standard lays out the required steps to be taken in managing risk for medical products.
Why it's useful
For a medical product, this is required by US and other international regulatory agencies. Additional methods are also employed to estimate risks before mitigation and after design mitigations. The chosen mitigations are then tracked to ensure they are in place and have the desired effect.
A good risk management process requires the creation of a risk management plan and a risk management file that captures the work and the output of the whole process. Risk management is an almost continuous process as more of the design is known and experience with the product in the real world is captured.
How to use it
This template is provided to allow the user to customize it for use in their quality system, and it is a complete, high-level risk management process. A similar company procedure has been reviewed by ISO auditors and found to meet the requirements of ISO 14971:2007 and ISO 13485. Each company must customize it for their specific needs and product types.
Sections 8 and 9 are offered as an example, showing how one company defined probability and severity and the resulting risk profile. In particular, your company's version of section 9 should be reviewed by your management team to ensure that they approve the risk profile. This is very dependent on the medical device type, intended use, and product classification.
During the early planning phase, the project manager should pull the team together to decide what specific analysis methods will be used to assess risk. For example, early on, when the concept is high-level and design has not started in detail, a System Hazard Analysis can be accomplished. As the design proceeds, other methods—such as FMEA, FMECA, and FTA—may be appropriate.
More detailed advice for applying this model throughout your product is included in the file.
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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