“Are FMEA or FMECA … good tools? Yes. They are very good tools that can be utilized.”
“Are they in and of themselves a risk management system? Absolutely not.”
“I can’t tell you how many manufacturers I have seen that have tried to present their risk management system by simply presenting a FMEA. That is NOT a risk management system.”
“Do not make the mistake of presenting FMEAs as your whole risk management system.”
— Kimberly A. Trautman QSR Expert CDRH, FDA
All device professionals know they have to perform risk management.
And to do it, many firms rely on the widely accepted standard for product risk management: Failure Modes and Effects Analysis (FMEA).
But with the FDA and international regulatory bodies ramping up risk management requirements — and the potential for serious injury (even death) present in many medical devices — is FMEA enough? Experts say no.
FDA QSR guru Kim Trautman lays it out very clearly: "I can’t tell you how many manufacturers I have seen that have tried to present their risk management system by simply presenting a FMEA. That is NOT a risk management system."
If that statement leaves you grasping to find new methods to assure you’re performing the best possible risk assessment, there are options.
Here are five additional methods drawn from the chemical, aerospace, nuclear and food safety industries:
- Event tree analysis (ETA)
- Fault tree analysis (FTA)
- Hazard analysis and critical control points (HACCP)
- Preliminary hazard analysis (PHA)
- Hazard and operability studies (HAZOP)
Where can you learn more about these methods? Why, at FDAnews' workshop, Medical Device Risk Management: From Understanding to Applications, of course.
Although these methods are less widely known and used within medical device companies, they can provide you with confidence that your products have passed rigorous risk assessment and management review. They can also demonstrate your commitment to compliance and patient safety to regulatory authorities.
This is just one example of the kind of invaluable insights you'll find at this always in demand FDAnews conference being led by Dan O'Leary, one of the industry’s chief risk management gurus and an esteemed instructor.
Here's more of what Dan will have in store for you when you attend Medical Device Risk Management: From Understanding to Applications. In two action-packed days, he will:
- help you establish, maintain and audit a highly effective risk management program implementing ISO 14971:2007
- show you how to integrate risk management with the FDA’s QSR and ISO 13485 quality management systems
- demonstrate the differences between hazards, harms and risks — and the unique tools to evaluate each one
- teach you to develop a risk evaluation matrix, assessing the probability of occurrence and the severity of harm
- tell you how to better use many types of risk management tools, such as FMEA, FTA and HAACP
- and much, much more.
And, as always, Dan will employ case studies throughout the two days to demonstrate effective risk management, plus involve conference registrants in 4 challenging interactive exercises:
- Is Risk in the Eye of the Beholder? Why risk is important … examples of failed risk management … plus a step-by-step method to help you recognize the amount of impact and loss.
- Simple Products Can Equal Complex Problems. Using a pop-up toaster as a mock medical device, you'll write a Risk Control Plan for the device, then work through the risk evaluation, discuss posible risk control plans, and write a Risk Management Report for the project.
- Building a Risk Management File. Employing mock data, you will evaluate production and post-production information and use it to evaluate the Risk Management File.
- Here Comes the Inspector. You'll play the role of Quality Auditor, examining other projects and employing tools you'll be able to take back to your company and use to audit your own programs.
Let's face it: today it's no longer good enough to understand the basics of risk management. You must be knowledgeable about how to build, maintain and audit risk management programs.
So, plan now to attend this two-day workshop and you'll soon be ready to set up a new comprehensive risk plan — or pick an existing one apart to make it better.
Do it now. Putting these programs in place assures that your company will develop safe and effective products … achieve competitive standing in the marketplace … and do it all with the confidence that you are fully complying with FDA and other international regulations. Register today.