Using the RRA® to Manage Medical Device Requirements Risk
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®.
"Harpco Systems provides some of the most technologically advanced FMEA software tools on the market, buts its their disciplined technique that further separates them from all the rest. Harpco breaks down the barriers and corrects the pitfalls so companies can reap the full benefits of FMEA. Class room training not only properly teaches FMEA, but participants actually build their business's FMEA as they go and are often blown away by how much work got accomplished. Harpco Systems has become known as the Modern FMEA for a reason. Its structured, simplified and sustainable. Thanks Richard for opening our eyes and the FMEA Flip is awesome!"
I have been working with Harpco Systems for 20 yrs and have seen how their products and services continue to improve to meet customer demands. Harpco’s training is first rate and helps develop new ways of thinking about the importance of creating proper specifications early. Separately, I’ve seen firsthand the effectiveness of using their approach in problem solving, helping to advance problems that had reached a stall using traditional methods.
Rich was asked to help us put together a Design Control and Risk Management program for our Immunodiagnostics products. Rich worked with us to build the necessary infrastructure to make the system comprehensive for the level of complexity needed to handle our products. During this time, Rich was not only helpful in putting the system in place, but also educating us on the thought process to evaluate product design and process control. In doing so, Rich provided us with the fundamental concepts to be able to decompose any product or process problem to arrive at an effective solution. He has left a lasting impression on our organization.
We were very fortunate to work with Rich Harpster and his team as we improved our DFMEA process at Calsonic. There is no better teacher, coach, implementer than Rich when it comes to creating a knowledge base for engineers to use in creating part specs to assure that products meet the customer's requirements.
"I would like to thank Harpco Systems for the help, advice and frankly the education in how to design, develop, source and manufacture new to world products. Not only was the Harpco Systems process scrupulously meticulous in making us evaluate, question, define and then justify every single aspect of our product design, project risks and manufacture process, it was done at a pace that saved us months by not following our conventional processes. By cutting out all the waste and focusing our resources on what was truly important Harpco Systems enabled us to get to a state of production readiness months ahead of our projected schedule. This combined with the incredibly detailed, well documented and most importantly correctly linked/associated technical and risk file information prepared us with a watertight project file with no liabilities missed. Harpco Systems has changed the way myself and others approach product design and development for the better."