1. Product Safety Consulting, Inc.© www.productsafetyinc.com Failure Mode and Effects Analysis - FMEA

2. Product Safety Consulting, Inc.© www.productsafetyinc.com FMEA -  What is it?  Why should we do them?  When should we do them?  What are the various types?  How do we do them?  What personnel need to be involved?

3. Product Safety Consulting, Inc.© www.productsafetyinc.com An FMEA is a part of an overall Risk Assessment of a product. It is a systematic method of determining possible failure modes and the risks associated with those failure modes.

4. SAFETY!!!  Products that undergo an appropriate safety program reduce the likelihood of causing harm!!  Many recalled products meet mandatory and voluntary Standards  Most Standards are prescriptive vs Hazard Base and don’t require Risk Assessments  Risk Assessments are being written into Standards – IT, Medical, Machinery, etc.

5. Product Safety Consulting, Inc.© www.productsafetyinc.com DISTRIBUTION PRODUCTION DEVELOPME NT CONCEPT DESIGN Increasing Time Investment Increasing Money Investment Increasing Emotional Investment

6. Product Safety Consulting, Inc.© www.productsafetyinc.com  Risk Hazard Exposure Driving Hazards to Zero is unrealistic. The idea is to minimize and manage Risk!!! RISK = ! x

7. Product Safety Consulting, Inc.© www.productsafetyinc.com  End Use – Identifies how the uses/mis- uses of a product can cause a hazard  Design – Identifies how the design can fail to cause a hazard  Process – Identifies how the process can fail to cause a hazard

8. Product Safety Consulting, Inc.© www.productsafetyinc.com  Standards –  Automotive - SAE J1739  Medical, other - IEC60812  Risk Priority Numbers - RPNs  Risk Based

9. Product Safety Consulting, Inc.© www.productsafetyinc.com  Call out the parts of the product  Determine Functions for each part  Determine Failure Modes  Determine Effects of the failures  Determine Causes of the failures  Determine Design Assurances to prevent the failures  Determine Risk Priority Number (RPN)  Determine how to mitigate the Risk  Determine Actions to Manage  Compare Results to Actions to Manage  Determine if more evaluation/investigation is needed  On-going effort!!

10. Product Safety Consulting, Inc.© www.productsafetyinc.com Severity of Consequence Probability of Mishap F Impossible E Improbable D Remote C Occasional B Probable A Frequent I Catastrophic II Critical III Marginal IV Negligible Risk Matrix Actions Category 1Operating risks are contained within acceptable levels. No corrective action is required Category 2Operating risks are not within acceptable levels. Corrective action plan must be recommended

11. Product Safety Consulting, Inc.© www.productsafetyinc.com  Unbiased Facilitator  Designer  Manufacturing  Consumer Affairs  Marketing  Legal  Experts

12. Product Safety Consulting, Inc.© www.productsafetyinc.com John Allen, President Product Safety Consulting, Inc. Phone: 630-238-0188, 877-804-3066 Email: jrallen@productsafetyinc.com Website: www.productsafetyinc.com