Medical Device Root Cause Analysis Training Course

Root cause analysis (RCA) is the essential investigation method used by RA/QA professionals to understand failures throughout a product’s life cycle. Often conclusions are drawn too quickly and problems resurface months later, affecting your time management, costing you money, and putting patient safety at risk.

Using workshops, case studies, and simulations, in this course you’ll work through the entire root cause analysis process, from creating a data-based problem statement, applying RC tools, and conducting data analysis for verifying the cause to selecting the best solution and determining its effectiveness. The goal: Create a problem-closing culture that allows your organization to both solve and recover from problems more quickly, apply project management in RCA, and document the root cause investigations.

This class is only available for private team training. For public training, see our related course CAPA and Root Cause Investigation Training for Medical Devices to learn how to identify and define the problem, AND then solve it.

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Course Dates

Upcoming Dates and Locations

Virtual seminars run as 1/2-day sessions. In-person classes run as full-day sessions. See the virtual session daily class times.

There are currently no public dates scheduled. All our courses are available to be held at a location of your choice. Please contact us for more information.

Course Details

What You Will Learn

At the conclusion of this workshop, you will be able to:

Learn how to properly define the scope of a problem and localize it.
Create an effective problem statement.
Gain insight into strategies for selecting problems based on risk and impact.
Choose appropriate methods of investigation (brainstorm, affinity diagram, 5 Whys, tree diagrams, cause and effect, and Is/IsNot).
Recognize the most appropriate data collection and analysis strategy.
Accurately define a problem, perform meaningful data analysis, select a solution selection, verify effectiveness, and manage the project.
Understand and apply the tools for successful root cause analysis.
Employ best practices for creating effective teams and monitoring their progress.
Verify root causes, properly document investigations, and audit the results.

Who Should Attend

This course is a good fit for anyone from the medical device industry participating in root cause analysis investigations.

Virtual Half-Days

5
In-Person Full-Days

3
CEUs

2.5

Virtual Session Details

The same great training, from the comfort of your home or office

Oriel STAT A MATRIX is known for our in-person workshops and hands-on activities, and we use an extensive toolbox to foster similar engagement and attention in our virtual classes. Our instructor and students interact in real time via our flexible, online learning platform, resulting in an engaging and real-class environment.

This is an ideal alternative to the typical classroom setting for quality and regulatory professionals who are unable to travel, work across various regions or loactions, or who just prefer the convenience of attending a class without having to leave their own personal environment.

This class can be delivered as a private virtual learning exclusively for your company.

Training Schedule

Standard delivery for this class is as five 3.5 hours sessions - 1:00 PM to 5:00 PM daily.

Technical /Logistical Requirements

To participate in this learning, first and foremost, we need your engagement! You will also need:

A computer with reliable, high-speed Internet connection. Broadband is preferable to WiFi.
Latest version of browser Firefox, Chrome, Microsoft Edge or Safari.
A USB-connected or built-in web cam.
A headset with microphone (USB connection recommended).
If possible, two monitors; one for the virtual classroom and the other for viewing training materials.
A comfortable workstation and a quiet environment.
To close your email browsers and refrain from using your phone during the training.

Tablets and mobile devices may lack some essential functionalities and are not recommended.

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Medical Device RA/QA

Quality System Audits for ISO 13485, FDA QSR, MDSAP

Performance Excellence

ISO 9000 & Related Standards

Connected Medical Devices, SaMD & IoMT

Medical Device Root Cause Analysis Training Course

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