Using The Application FMEA To Manage Product Usage Risk
(Note: Training offered in both class and workshop format)
The Product Usage Risk Management Process fails any time a Product Design Specification (i.e. dimension, material property and/or software code) is released to manufacturing and/or Product Usage Instructions are released for customer use that results in a product failing due to the way it is used. When this happens both the company who designed the product and the end customer are exposed to risk.
Although no failures due to usage is the goal, the Product Design Specifications and Product Usage Instructions must be optimized to define a product that does not exceed a failure rate that is acceptable to the customer and the company who designed the product. Also referred to as an “Usage Risk Assessment” or “URA®“, the Application FMEA provides a systematic method for accomplishing this task. Using a product of the classes choice, attendees will learn how to use the Application FMEA to “risk optimize” the Product Design Specifications and Usage Instructions.
The key role that the Application FMEA plays in meeting the risk-based thinking requirements of ISO 9001:2015 and IATF 16949 will be explained.
Using a product of the classes choice, attendees will learn how to use the Application FMEA to “risk optimize” the Product Design Specifications and Product Usage Instructions.
If material is presented using a multi-day Workshop, the goal is to provide an Application FMEA of “Customer Delivery Quality” as well as educate attendees on the fundamentals of their use and creation.
Who Should Attend
All personnel who are responsible for the creation and maintenance of product designs and Product Usage Instructions should attend the class.
Students must have knowledge of the product design and use of the product that they choose to use for the class exercises. If they exist, the Design FMEA and Product Usage Instructions for the product that the Application FMEA will be developed for should be brought to the session.
Class (One Day); Workshop (Two to three Days depending on product complexity).
What is an Application FMEA
Why perform an Application FMEA
When to perform an Application FMEA
Who should participate in the Application FMEA process
How to conduct an Application FMEA:
- How to create a Process Path for the Application FMEA;
- Two types of Application FMEA Failure Modes;
- Defining Failure Mode Effects;
- How to determine Severity (SEV) ratings in two minutes or less;
- Creation of the Application Specification Analysis;
- Nine sources of application failure;
- How to determine Occurrence (OCC) ratings in 15 seconds or less;
- The difference between prevention and detection controls;
- How to calculate the Risk Priority Number (RPN) and why it should be rarely used to determine what to work on;
- How to determine Class designations in the Application FMEA and their importance in determining what must be worked on.
How to Construct an Application Control Plan.