Using the RRA® to Manage Medical Device Requirements Risk
(Note: Training offered in both class and workshop format)
The Requirements Definition Process fails any time a Customer Requirement or Medical Device Design Requirement (Medical Device Design Requirements are Customer Requirements translated into language of designers) is released for design that results in a medical device being designed that does not meet the Customer Requirements. When this happens both the company who designed the product and the Customer are exposed to risk. Unfortunately, due to the volume of Customers and Customer Requirements for a medical device and the fact that some Customer Requirements may compete, it is often impossible to define Customer Requirements and Medical Device Design Requirements that define a product that will meet all the Customer Requirements.
Although meeting all Customer Requirements is the goal, the Customer Requirements and Medical Design Requirements 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. The RRA® (Requirements Risk Assessment®) provides a systematic methodology to allow companies to define Customer Requirements and Medical Device Design Requirements that minimize risk while providing medical devices with best in class benefits. Using a product of the classes choice, attendees will learn how to use the Requirements Risk Assessment® (RRA®) and Design Validation Plan to “risk optimize” Customer Requirements and Medical Device Design Requirements.
The Key role that the RRA® plays in meeting the risk-based thinking requirements of ISO 13485:2016 will also be explained.
If material is presented using a multi-day Workshop, the goal is to provide RRA® and Design Validation Plan 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 Customer Requirements and Product Design Requirements should attend the class.
Students must have knowledge of the product that they choose to use for the class exercises. If they exist, Customer Requirements documents and Product Design Requirements for product that documents will be developed for must be brought to the session.
Class (One Day); Workshop (Two to four Days depending on product complexity).
Key Concepts Covered:
- Why the RRA® is the most important process a company can implement to reduce risk;
- The role of the Requirements Risk Assessment (RRA®), Design FMEA (System, Subsystem, Component), Process FMEA, Design Validation Plan, Design Verification Plan and Process Control Plan in Risked Based PLM®;
- Linkages between RRA®, Design FMEA, Process FMEA, Design Validation Plan, Design Verification Plan and Process Control Plan;
- Common mistakes made when capturing the voice of the customer;
- Detecting and defining “undefined customer requirements”;
- High cost of incorrect or undefined customer requirements;
- Common mistakes made when defining design requirements;
- High cost of incorrect or undefined design requirements;
- How the customer type affects the RRA® methodology to be used;
- Step by step method for performing RRA®.