ASQ 706 - October 2018: Applying FMEA to Medical Device Development
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Challenges of Applying FMEA Tools into the Medical Device Development
The FMEA (Failure Mode and Effect Analysis) was initially formalized in 1949 by the U.S. military in MIL-P-1629. Since that time, FMEAs have been successfully applied in various fields including the Apollo space program, civil aviation, environmental protection, the automotive, semiconductor and food service industries, the plastics sector, software, and healthcare. There are many standards and guidelines published that cover the scope and general procedures for doing FMEAs or FMECAs, such as SAE J1739, AIAG, MIL-STD 1629A, IEC 60812. Since FMEAs are able to shift problem discovery earlier in the product development process, the early detection of failures helps reduce project risks and minimize the cost of changes.
Since ISO 14971 is a standard for the application of risk management in the medical device industry, every medical device company has to remediate risk management files (traditional FMEAs) into new templates. Many organizations hire quality engineer consultants (also called risk management engineer consultants) to work on costly and time-consuming remediation activities.
This presentation will explore the major challenges of building these new FMEA templates and updating risk management files from gaps between FMEAs vs ISO 14971, FMEAs vs cross-functional teams, FMEAs vs post market surveillance, and FMEA vs Risk management report annual reviews.
In the end, a risk management software (RdPDM V3.0) program is introduced to show one unified FMEA worksheet for all types (etc. design, process, application, software, system) and all status (e.g. pre-market, post-market). The software allows you to export FMEA worksheets into excel files and generate risk management files. It is able to visualize the gap between FMEA vs. customer complaints and further push FMEA files updated in the course of RMR annual reviews. This software can save a significant amount of time and money when a FMEA needs to be updated or remediated (e.g. hazard, hazardous situation, harm, severity level, risk region).
By attending this presentation, you will:
Understand basic FMEA history, standards, success, and limitation
Realize challenges for applying FMEA into medical device development
Overview risk management software effectively and efficiently facilitates FMEA activities
Jerry (Jinxing) Xiao and John Spanomanolis
Jerry (Jinxing) Xiao joined ASQ in 2007 and obtained his CQE, CQA, CSSBB and CRE from ASQ. He has worked successfully as a quality professional in China, Canada, and the U.S. During recent years, his quality practices focus on product development for the medical devices in pre-market and post-market stages. Jerry has been involved with medical devices such as the Total Artificial Heart, the Pacemaker, Implantable Cardioverter Defibrillators (ICD), Doctor Robot, Pumps (Insulin, Infusion), Ventilator, Orthopedic Products, Lead, Catheter from Johnson & Johnson, Medtronic, Philips healthcare, Abbott (St Jude Medical), BD, Zimmer Biomet, etc.
Jerry (Jinxing) holds a Bachelor Degree in Engineering and a Master’s Degree in Quality Systems Engineering. He is the business owner of RdQCC (Risk driven Quality Consulting Company LLC), located in San Diego, California.Please join us!