Fault Tree Analysis and Design FMEA – mitigate risk of Failure during the Design & Development Process per ISO 14971
WHAT IS A FAULT TREE ANALYSIS AND A DESIGN FAILURE MODE AND EFFECTS ANALYSIS
Effectively designed products ensure that the overall product life cycle cost is minimised. To ensure that a proposed product design meets its customer expectations right the first time, it is critical to minimise risks. Two processes can be applied to identify potential risks, rank their severity and identify sources of failures. These are the Fault Tree Analysis (FTA) and Design Failure Mode and Effects Analysis (dFMEA). Both use a structured approach to rank the severity of failure modes or hazards and, based on this rating, identify mitigating actions.
PROGRAM AIM
The aim of this program is to provide the knowledge and skills to prevent occurrence of failures and hazards in a new product, service or process. This is achieved by identify and ranking potential hazards and failures during process development and identifying actions to mitigate theses risks. This course also complies with ISO9001:2008 and ISO13485:2003 Design and Development requirements.
TARGET AUDIENCE
This course is aimed at personnel who are involved in the design of new products and processes. It is also suitable for personnel considering integrating risk based methodologies into their design processes.
PRE REQUISITES This course assumes little to no experience of FTA and dFMEA Methodologies
PROGRAM OBJECTIVES
At the end of this course, you will be able to:
1. Identify hazards and rank hazards of a design using a Fault Tree Analysis
2. Identify failure modes of a design and rank their risks using Design Failure Mode and Effects Analysis
3. Select high and medium risks of the design and identify mitigating actions to minimise these risks.
PROGRAM SYLLABUS
Session 1 What is a Root Tree analysis and Design FMEA?
Session 2 What are the benefits of using these tools?
Session 3 Where do these tools apply in the Design and Development Process?
Session 4 Introduction to a Root Tree Analysis
Session 5 How to complete a Root Tree Analysis: Data required, personnel required, process
Session 6 Select risks that require mitigating actions and determine appropriate actions
Session 7 Introduction to a Design Failure Mode and Effects Analysis (dFMEA)
Session 8 How to complete a dFMEA: Data required, personnel required, process
Session 9 Select potential failure modes that require mitigating actions and determine appropriate actions
Session 10 Assessment of Learning
ASSESSMENT
On completion of training, trainees will complete a short multiple choice exam.
ABOUT THE TRAINER
The trainer for this course is Maria Ryan, who is a certified Six Sigma Black Belt and Level 6 FETAC certified trainer. Maria has 15 years industrial experience within the Aerospace, Chemical, Medical Device and Pharmaceutical environments. Within these industries, she has worked in varying roles including Design and Manufacturing Engineer, Six Sigma Black Belt, Continuous Improvement Manager, Quality Manager and Process Excellence Leader. On completion of training, trainees are motivated to apply learning on return to the workplace. This is achieved through practical application of tools coupled with Maria’s high energy and passion for superior performance.
INCLUDED IN COST
- Certificate of Attendance and Assessment
- Venue, Refreshments and Lunch
- Comprehensive Notes and Reference Material
- Supply of a dFMEA procedure and templates and FTA templates for immediate application on return to work
CONTACT DETAILS
Contact Name: Maria Ryan, Training Course Manager
Mobile: +353 87 6226899
e-mail: maria.ryan@crystalbusinesssolutions.ie
Website: www.crystalbusinesssolutions.ie
Registration: Training Registration Form
Training Calendar: Calendar
PROGRAM DURATION 1 day
PROGRAM COST €280.00 per person