Process FMEA And Control Plans For Medical Devices 2017-03-02T10:35:52+00:00

Effective Process FMEA And Control Plans Implementation And Use

(Medical Devices Version)

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

Objectives

  1. (Class, Workshop)

    Give attendees an in depth knowledge of how the Process FMEA and Process Control Plan are used to develop better manufacturing and assembly processes while reducing risk.

  2. (Workshop)

    If Design FMEA is not available or inadequate, develop Specification Analysis replacement.

  3. (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

  1. All personnel who are responsible for a manufacturing and/or assembly process.
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

  1. Attendees must have knowledge of the product and process that they choose to use for the workshop.
  2. Experts in the maintenance and operation of the process equipment must be present to successfully develop the Process FMEA and Process Control Plan.

Duration

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

Overview

  1. Introduction:
    1. The role of the Requirements Risk Assessment (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 Verification Plan, Design Verification Plan and Process Control Plan.
  2. How to Perform a Process FMEA:
    1. Seven step process for creating a Process Flow diagram;
    2. Elements of the Process FMEA that can be derived by the System FMEA and Design FMEA if they exist;
    3. What to do if no Design FMEA exists;
    4. Quality related failure modes;
    5. Non-quality related failure modes;
    6. Failure mode effects;
    7. How to determine Severity (SEV) ratings in two minutes or less;
    8. Three most common mistakes when filling out the Process FMEA Failure Cause column;
    9. Ten sources of process variation that must be considered when filling out the Failure Cause column;
    10. How to determine Occurrence (OCC) ratings in 15 seconds or less;
    11. The difference between prevention and detection controls;
    12. How to determine Detection (DET) ratings in 15 seconds or less;
    13. How to calculate the Risk Priority Number (RPN) and why it should be rarely used to determine what to work on;
    14. How to determine Class designations in the Process FMEA and their importance in determining what must be worked on;
    15. The impact of class designations in the Process FMEA on the Process Control Plan;
    16. The only allowable types of Recommended Actions.
  3. Medical Device Type:
    1. Implantable:

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

    2. Non-Implantable:

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

  4. How to Construct a Process Control Plan:
    1. The purpose of the Process Control Plan;
    2. How the Process FMEA can be used to assist in filling out the Process Control Plan;
    3. Why a properly constructed Process Control Plan normally has 10 entries in the Process Characteristic Column for each entry in the Product Characteristic Column;
    4. How to use the Process Control Plan.
  5. Closing:
    1. Alternate uses of the information contained in the Process FMEA;
    2. Obstacles to implementing Process FMEAs and Process Control 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