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).
- 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;
- Linkages between RRA®, Design FMEA, Design FMEA, Process FMEA, Design Verification Plan, Design Verification Plan and Process Control Plan.
How to Perform a Process FMEA:
- Seven step process for creating a Process Flow diagram;
- Elements of the Process FMEA that can be derived by the System FMEA and Design FMEA if they exist;
- What to do if no Design FMEA exists;
- Quality related failure modes;
- Non-quality related failure modes;
- Failure mode effects;
- How to determine Severity (SEV) ratings in two minutes or less;
- Three most common mistakes when filling out the Process FMEA Failure Cause column;
- Ten sources of process variation that must be considered when filling out the Failure Cause column;
- How to determine Occurrence (OCC) ratings in 15 seconds or less;
- The difference between prevention and detection controls;
- How to determine Detection (DET) ratings in 15 seconds or less;
- How to calculate the Risk Priority Number (RPN) and why it should be rarely used to determine what to work on;
- How to determine Class designations in the Process FMEA and their importance in determining what must be worked on;
- The impact of class designations in the Process FMEA on the Process Control Plan;
- The only allowable types of Recommended Actions.
How to Construct a Process Control Plan:
- The purpose of the Process Control Plan;
- How the Process FMEA can be used to assist in filling out the Process Control Plan;
- Why a properly constructed Process Control Plan normally has 10 entries in the Process Characteristic Column for each entry in the Product Characteristic Column;
- How to use the Process Control Plan.
- Alternate uses of the information contained in the Process FMEA;
- Obstacles to implementing Process FMEAs and Process Control Plans effectively.