Quality Risk Management for Medical Device
This Quality Risk Management training course is designed to help effectively manage risks as a formalized system for medical device manufacturing. Course participants will learn principles and applications as they apply specifically to ISO 14971:2012. They will become acquainted with the necessary tools, techniques, tips and skills for effective implementation of risk management in their quality system. Understand how to effectively manage risk for patients, operators, equipment, and the surrounding environment. m
Attendees of the PathWise Quality Risk Management Training learn how to:
- Demonstrate what is important about your business and safe for customers.
- Identify the components of the quality risk management process in a Medical Device manufacturing environment.
- Understand roles and responsibilities in risk management.
- Discuss hazards and risks in designs, systems, and processes.
- Appropriately apply Quality Risk Assessment tools.
- Connect risk review to your company’s quality system processes.
- Provide a documented, approved rationale for your decisions.
The Quality Risk Management Training contains the following modules:
- Quality Risk Management Introduction – Define risk and identify roles in risk management. Explain current regulatory requirements for risk management, specifically ISO 14971:2012, and identify the components of the quality risk management process.
- Quality Risk Management Process and Tools – Initiate a risk project and identify appropriate personnel for a quality risk management team. Then, apply and establish risk acceptance criteria for the project using tools such as, process maps and brainstorming. Step-by-step walk through of the regulations and risk process including detailed risk assessment and control activities. In depth activities focus on risk identification, analysis, evaluation, reduction and acceptance. Ensure the risk management process is effective, tracks events that might impact the original risk management decisions. Also, learn expectations for monitoring and reviewing risk.
- Failure Mode Effects Analysis (FMEA) Tool- The FMEA tool is often the first step of a system reliability study. It involves reviewing as many components, assemblies, and subsystems as possible to identify failure modes, and their causes and effects. For each component, the failure modes and their resulting effects on the rest of the system are recorded in a specific FMEA worksheet.
- Fault Tree Analysis (FTA) Tool- The FTA is a tool used in a risk based system to identify any pertinent factors that contributed to an undesired event. The tool is an effective tool in order to identify potential causes or pathways to the event or failure.
- How to employ critical thinking when identifying risks
- How to create a working FMEA document to support QRM methodology
- Reduce risk in systems and processes
- Improve risk awareness
- Identify risk measures
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Risk Based Decision Making in the Quality System
We understand that training is essential to achieve and maintain a compliant, effective and efficient quality system, which is why 90% of our courses are taught on-site at our client’s locations. For individuals and organizations in need of training but unable to make an on-site training commitment, we offer many of our courses as events at a variety of locations across the globe.
View the PathWise Events page to find out about our options for a public workshop.