Failure Mode and Effects Analysis-FMEA

INTRODUCTION

Ahigh Quality Product that conforms to intended purpose that usually results in High customer satisfaction. The best way to achieve this is to builtd Quality in design upfront in manufacturing itself rather than restoring to rigorous inspection later on.

A useful quality Engineering Tool for that purpose is Failure Mode effect Analysis (FMEA). 

Failure Mode and Effect Analysis (FMEA) is one of the most powerful and practical reliability tools in manufacturing today .Many companies used FMEA to successfully improve product designs and Manufacturing processes. It has been referenced in USFDA Pre-production quality planning bulletin (FDA 90-4236) and in ISO 9001 quality standards as an effective tool for ensuring quality product design and manufacture. New standards for medical device risk analysis (EN 1441 and ISO 14971-1) as well as FMEA(IEC 812) specifically address the application of FMEA .It can also be use for product development,design and manufacturing. It also focuses on design and process FMEA .It can also be used to improve field service efforts and the system. It also helps in identifying potential failure modes,assess the risk of failure,evaluate possible causes and implement solutions. It also helps to establish priorities and organize resources to correct potential problems. 

FEMA can be used to:

1. Design your products right the first time.
2. Improve the control over your design process
3. Reduce the cost and improve the quality of your manufacturing processes.
4. Reduce the time to get your products to market.
5. Focus on function based features during product deign and manufacturing planning.
6. Eliminate non value added manufacturing steps
7. Prevent costly and time consuming engineering design changes
8. Improve product performance and customer satisfaction
9. Establish and verify manufacturing process capability
10. Improve product design validation process
11. Implement effective manufacturing controls such as SPC,control plans and CpK calculations.
12. Develop manufacturing specifications that meet your product design requirements.
13. Integrate design and process FMEA into TQA and reliability program
14. Predict potential design and manufacturing related problems early,before they occur so you can take corrective actions before damage is done.
15. Use FMEA to avoid costly product field failures.
16. Apply a systematic approach to integrating information from customer service, field complaints, reliability studies, quality and inspection data and testing data to improve new product designs and manufacturing processes.