Standard Training Classes/Workshops

RAMS

Using Machinery FMEAs to Manage Tooling Design Risk

Objectives

The Tooling Design Process fails any time a Tooling Design Specification (i.e. dimension, material property and/or software code) is released to Tooling manufacturing that results in a Tooling being built that does not meet one or more of its design requirements. When this happens both the company who designed the Tooling and the end customer are exposed to risk.

Unfortunately, due to the volume of design requirements for Tooling and the fact that some design requirements may compete, it is often impossible to define Tooling Design Specifications that define Tooling that will never fail. Although no design failures are the goal, the Tooling Design Specifications must be optimized to define a Tooling that does not exceed a failure rate that is acceptable to the customer and the company who designed the Tooling. The Machinery FMEA and its supporting Design Verification Plan provide a systematic method for accomplishing this task. Using Tooling of the class’s choice, attendees will learn how to use the Machinery FMEA and Design Verification Plan to “risk optimize” the Tooling Design Specifications.

Along with the Machinery FMEA fundamentals, attendees will learn the common mistakes found in 99% of Machine FMEAs and how to avoid them. They will also be shown how to spend an average of 15 seconds or less on each Machinery FMEA rating thus removing one of the most significant ways people waste time when performing Machinery FMEAs.

The Key role that the Machinery FMEA and Design Verification Plan play in meeting the risk-based thinking requirements of ISO 9001:2015 and IATF 16949 will be explained.

If material is presented using a multi-day Workshop, the goal is to provide Machinery FMEA and Design Verification Plan of “Customer Delivery Quality” as well as educate attendees on the fundamentals of their use and creation.

Who Should Attend

  1. All personnel who are responsible for the creation and maintenance of machinery designs.

Prerequisites

  1. Attendees must have knowledge of the machinery that they choose to use for the Workshop exercises.
  2. If they exist, Requirements Risk Assessment (RRA®), Machinery Design Requirements documents, prints and bill of materials for the selected machinery.

Duration

  1. Class Duration: 1 day;
  2. Workshop Duration: 3-4 days, depending on machinery served.

Overview

  1. Introduction:
    1. The role of the Machinery Requirements Risk Assessment (RRA®), Machinery FMEA, Process FMEA, Design Validation Plan, Design Verification Plan and Process Control Plan in the machinery development process;
    2. Linkages between Machinery RRA®, Machinery FMEA, Process FMEA, Design Validation Plan, Design Verification Plan and Process Control Plan.
  2. How to Perform a Machinery FMEA:
    1. Elements of the Machinery FMEA that can be derived from the Machinery RRA® 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 Machinery FMEA failure cause;
    7. How to determine Occurrence (OCC) ratings in 15 seconds or less;
    8. Determining the contents and adequacy of the Machinery Preventative Maintenance Plan;
    9. The difference between prevention, detection and mitigation controls;
    10. How to determine Detection (DET) ratings in 15 seconds or less;
    11. How to calculate the Risk Priority Number (RPN) and why it should be rarely used to determine what to work on;
    12. How to determine Class designations in the Machinery FMEA and their importance in determining what must be worked on;
    13. Why Class designations in the Machinery FMEA are not transferrable to the Process FMEA;
    14. The only allowable types of Recommended Actions.
  3. How to Construct a Machinery Design Verification Plan:
    1. The purpose of the Machinery Design Verification Plan;
    2. How the Machinery FMEA can be used to assist in filling out the Machinery Design Verification Plan;
    3. How to use the results of the Machinery Design Verification Plan.
  4. Closing:
    1. Alternate uses of the information contained in the Machinery FMEA;
    2. Obstacles to implementing Machinery FMEAs and Machinery Design Verification Plans effectively.



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"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!"

Chris FollisChris Follis, Regal Beloit Director of Quality

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.

Todd GrossTodd Gross, VP of Global Quality
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.
Scott Richards, Manager, Risk Management at Abbott Diagnostics
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.
Marv BeasleyMarv Beasley, Director of Engineering
"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."
Jonathan Flood, Engineering Manager