Requirements Risk Assessment For Medical Devices 2017-03-02T10:35:52+00:00

Reducing Requirements Related Risk Using the Requirements Risk Assessment (RRA)

(Medical Device Version)

(Note: Training offered in both class and workshop format)

Objectives

  1. (Class, Workshop)

    Give attendees an in depth knowledge of how to properly define optimized design requirements in order to develop better product designs while reducing risk.

  2. (Workshop)

    Make significant progress if not complete the RRA® for product selected for workshop.

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 infrustructure 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.
Scott Richards, Manager, Risk Management at Abbott Diagnostics

Who Should Attend

  1. All personnel who participate in capturing the voice of the customer.
  2. All personnel who participate in the definition of design requirements.

Prerequisites

  1. Students must have knowledge of the product that they choose to use for the Workshop.

Duration

  1. Class Duration: 1 Day;
  2. Workshop Duration: 3-4 days, depending on medical device served.

Overview

  1. Key Concepts Covered:
    1. Why the RRA® is the most important process a company can implement to reduce risk;
    2. 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®;
    3. Linkages between RRA®, Design FMEA, Process FMEA, Design Validation Plan, Design Verification Plan and Process Control Plan;
    4. Common mistakes made when capturing the voice of the customer;
    5. Detecting and defining “undefined customer requirements”;
    6. High cost of incorrect or undefined customer requirements;
    7. Common mistakes made when defining design requirements;
    8. High cost of incorrect or undefined design requirements;
    9. How the customer type affects the RRA® methodology to be used;
    10. Medical Device Type:
      1. Implantable:

        Step by step method for performing RRA® for implantable device including tools used for implantation and implant site preparation;

      2. Non-Implantable:

        Step by step method for performing RRA® for non-implantable medical device

    11. Step by step method for performing RRA®.
    12. Using the results of RRA® to identify and mitigate risk.
Want to schedule this class? Call us today at (248) 374-1718 or fill out the form for more info.

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“Harpco breaks down the barriers and corrects the pitfalls so companies can reap the full benefits of FMEA. Classroom 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.”
Chris Follis, Regal Beloit Director of Quality
“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.”
Todd Gross, VP of Global Quality
“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.”
Jonathan Flood, Engineering Manager
“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. Rich teaches the basics, then he accelerates the FMEA process so that requirements and specs are related in a database that can be continually updated.”
Marv Beasley, Director of Engineering