A biomedical research company sought to increase worker knowledge in the use and application of the Failure Mode Effects Analysis (FMEA) quality tool. The company desired a pragmatic approach with a combination of theoretical understanding of how the tool might be used, and a practical application of the use of the tool with one or more current products.
A Performance Validation Principal Engineer, with experience in Pharmaceutical, Medical Devices, and Combination Products who is also an American Society for Quality Certified Quality Engineer was selected for this project.
Performance Validation coordinated with the client point of contact to develop 2-day training approach that focused on the value add of the FMEA process in product development (risk identification, risk ranking, and mitigation), and less on the mechanics of risk priority numbering (RPN) calculations. This resulted in the following approach:
The training was successfully completed over a 2-day period with approximately 15 client staff. All required training objectives were met. The staff participating in the training were all scientists with prior exposure to hazard analysis as part of the product development process.
Client staff who participated in the training obtained a solid foundation in how to conduct and integrate the Failure Modes Effect Analysis into product design and design transfer, specifically use of the FMEA:
For additional information, contact:
Vice President & Division Director, Indiana
Performance Validation, LLC.
5420 W Southern Ave, Suite 100
Indianapolis, Indiana 46241