Using The Process FMEA & Control Plan to Manage Medical Device Manufacturing Process Risk

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


The Manufacturing Process fails any time a Manufacturing Process has been released for use and then fails to meet a performance requirement. When this happens, the company who owns the Manufacturing Process, company employees using the Manufacturing Process and the end customer can be exposed to risk. Although no Manufacturing Process failures is the goal, resource availability is limited so its use must be optimized to obtain a performance level acceptable to anyone exposed to risk when the process fails. The Process FMEA and its supporting Process Control Plan provide a systematic method for accomplishing this task.

Using a medical device and process of the class’ choice, attendees will learn how to use the Process FMEA and Process Control Plan to “risk optimize” the manufacturing process.

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

The key role the Process FMEA and Process Control Plan play in meeting the risk-based thinking requirements of ISO 13485:2016 will be explained.

If material is presented using a multi-day Workshop, the goal is to provide a Process FMEA, Process Control Plan and Process Validation 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 medical device manufacturing processes should attend the class.


Students must have knowledge of the product and process that they choose to use for the class exercises. If they exist, prints, bill of materials and Design FMEA for product and process that the Process FMEA, Process Control Plan and Process Validation Plan will be developed for should be brought to the session.


Class (One Day); Workshop (Two to five Days depending on product and process complexity).


  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. 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.
  4. Closing:
    1. Alternate uses of the information contained in the Process FMEA;
    2. Obstacles to implementing Process FMEAs and Process Control 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!"

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."
Jonathan Flood, Engineering Manager