“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
As a device professional, you know you have to perform risk management.
And to do it, many firms rely on the widely accepted technique for reliability: 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 startled and wondering about your risk management strategies, we have your solution.
Make plans today to attend, Medical Device Risk Management: Developing the Total Program. Limited seating exists for this always in demand FDAnews workshop led by Dan O'Leary, one of the industry’s chief risk management gurus and an esteemed instructor.
Here's what Dan will have in store for you when you attend Medical Device Risk Management: Developing the Total Program. In two action-packed days, he will:
- help you transition from the now obsolete IEC 62366:2007 to the updated IEC 62366-1:2015 — don’t get caught during your next inspection applying an out-of-date standard!
- discuss the limitations on risk management activities from the EU product directives (MDD, IVDD, and AIMD) documented in EN ISO 14971:2012
- help you establish, maintain and audit a highly effective risk management program implementing ISO 14971:2007 and EN ISO 14971:2012
- show you how to integrate risk management with the FDA’s QSR, ISO 13485:2003, and ISO 13485:2016 quality management systems (easier said than done, and most firms can’t really show regulators sufficient documentation)
- demonstrate the differences among 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 and relating them to risk
- 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. You’ll get out of your seats and actively participate with your colleagues in 4 challenging hands-on exercises:
- Is Risk in the Eye of the Beholder? Why risk is important … examples of failed risk management.
- Simple Products Can Equal Complex Problems. Using an electric tooth brush as an example, you'll identify hazards, hazardous situations, and harms; discuss risk control measures; and evaluate residual risk.
- Building a Risk Management File. Employing mock data, you will evaluate production and post-production information and use it to update 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 management system — or pick an existing one apart to make it better.
Do it now. Putting these programs in place helps assure 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.