The Challenge

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.

The solution

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:

• Pre-work: Basics of FMEA and quality tools to gain a preliminary understanding of the tool prior to training.
• Session 1: Classroom portion on FMEA process, quality tools, and supporting techniques.
• Session 2: Practical FMEA generation. A facilitated discussion through the FMEA process of brainstorming/failure identification for 1 or 2 client selected projects.
• Session 3: Practical FMEA generation continued. A facilitated discussion through the FMEA process of scoring, RPN generation, and mitigation of risks.
• Session 4: Classroom session on integration of quality tools and techniques such as use of Ishakawa diagrams to identify Critical Quality Attributes, Failure modes and analysis. How to use FMEA in:
  • Product design to prevent or mitigate failures.
  • Design manufacturing process that prevent or mitigate identified risks.
  • Develop QC plans that detect failures anticipated by the FMEA.

The Results

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.

The Benefits

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:

• Identified new design requirements on several new product development projects.
• Helped identify specific manufacturing controls that could prevent problems and also can make troubleshooting more straightforward if failures occur.
• Reduced reliance on Functional Testing of finished product, and helped identify more specific tests and tests that can be moved “upstream” in manufacturing.

For additional information, contact:
Brad Henry
Vice President  & Division Director, Indiana
Performance Validation, LLC.
5420 W Southern Ave, Suite 100
Indianapolis, Indiana 46241