Are you responsible for process and quality assurance functions (risk analysis) for critical characteristics on disposable medical devices?
Must you detail, in chronological order, all manufacturing risks associated with your production processes (so your customers can see your risk management is planned and complete)?
Are you manufacturing an FDA product (or a product that requires the CE Mark) that requires proof of cGMP (current Good Manufacturing Practices) or ISO-14791 (risk analysis) compliance?
The article “How to do a Process FMEA for Medical Devices after ISO-17791 Risk Analysis” (which includes an example of a Process FMEA form) attempts to help you understand the methods and control points in the contract review and risk analysis phases of your product development. These are items that the FDA and/or customer auditors will be looking for.
To view an FMEA flowchart, please click here.