Design FMEA For Medical Devices 2017-03-02T10:35:52+00:00

Effective Design FMEA Implementation and Use

(Medical Device Version)

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

Objectives:

  1. (Class, Workshop)

    Give attendees an in depth knowledge of how the Design FMEA and Design Verification Plan are used to develop better product designs while reducing financial risks to the company.

  2. (Workshop)

    Make significant progress if not complete the development of Design FMEA and Design Verification Plan for a product of the class’s choice.

Who Should Attend:

All personnel who are responsible for the creation and maintenance of product designs should attend the class.

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

Prerequisites:

Students must have knowledge of the product that they choose to use for the class exercises. If they exist, Requirements Risk Assessment (RRA®), Product Design Requirements documents, prints and bill of materials for product(s) that the Design FMEA and Design Verification Plan will be developed for must be brought to the workshop.

Duration:

  1. Class Duration: 1 day;
  2. Workshop Duration: 3-4 days depending on product selected.

Overview:

  1. Introduction:
    1. The role of the RRA®, Design FMEA, Process FMEA, Design Validation Plan, Design Verification Plan and Process Control Plan in the product development process;
    2. Linkages between RRA®, Design FMEA, Design FMEA, Process FMEA, Design Validation Plan, Design Verification Plan and Process Control Plan.
  2. How to Perform a Design FMEA:
    1. Elements of the Design FMEA that can be derived by the Requirements Risk Assessment if one exists;
    2. Eighteen categories of design requirements that must be considered;
    3. Typical and special case failure modes;
    4. Typical and special case effects;
    5. How to determine Severity (SEV) ratings in two minutes or less;
    6. Two required elements of a Design FMEA failure cause;
    7. How to determine Occurrence (OCC) ratings in 15 seconds or less;
    8. The difference between prevention and detection controls;
    9. How to determine Detection (DET) ratings in 15 seconds or less;
    10. How to calculate the Risk Priority Number (RPN) and why it should be rarely used to determine what to work on;
    11. How to determine class designations in the Design FMEA and their importance in determining what must be worked on;
    12. Why class designations in the Design FMEA are not transferrable to the Process FMEA;
    13. The only allowable types of Recommended Actions.
  3. Medical Device Type:
    1. Implantable:

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

    2. Non-Implantable:

      Step by step method for performing DFMEA for non-implantable medical device

  4. How to Construct a Design Verification Plan
    1. The purpose of the Design Verification Plan;
    2. How the Design FMEA can be used to assist in filling out the Design Verification Plan;
    3. How to use the results of the Design Verification Plan.
  5. Closing
    1. Alternate uses of the information contained in the Design FMEA;
    2. Obstacles to implementing Design FMEAs and Design Verification Plans effectively.
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