Appendix A I Appendix B I Appendix C

In view of Alcon's ITC quality policy, we constantly have to strive to improve our quality/reliability of our products while reducing the cycle time and cost of our products. I just know that we can do a lot better! Many other medical device companies have already implemented one of the above described methods with substantially improved product quality/reliability, reduced cycle time and sharply reduced warranty expense. If Alcon wants to stay the worldwide leader of eye surgical systems, we constantly have to rethink our processes and methods.

I highly recommend investigating the accelerated aging methods to replace our old-fashioned test methods. We need a clear relation between our test methods and actual warranty life and use conditions.

I envision that the product development teams would do the initial investigation of the product with accelerated aging. This would allow them to mitigate any defects and improve the design. It also would save us from opening a CAPA for reliability improvement, once the product is released. Then a P/F test could be developed as a verification test for the product certification group. From those results a manufacturing screening test could be derived.

The resulting benefits would be a substantial reduction in device related complaints and reduced repair and service expense. Every company that has implemented any of these methods have saved millions in the first year alone and substantially improved their customer's satisfaction. Often this resulted in increased sales and improved market share.

Notes
^1. Dr. Gregg K. Hobbs is the originator of and world leader in the principles of HALT and HASS. He has been a consulting engineer since 1978, specializing in the fields of stress screening, robust and flaw tolerant design, dynamic analysis and testing. He has been employed as a consultant by many leading companies in the aerospace, commercial, military and industrial fields. He has taught courses on these subjects in the USA, Asia, Canada, Europe, Africa, and the Middle-East. Over the past twenty-nine years, Dr. Hobbs has shown thousands of engineers throughout the world how to improve the quality of their products through the application of his HALT and HASS accelerated reliability techniques. RapidHALT™, introduced in 2003, has reduced the time in HALT substantially. Other significant improvements in the HALT and HASS methodologies were made by Dr. Hobbs in 2004. HyperHALT™ was introduced in 2007.

^2. HALT/HASS profiles adapted from Martek Power, Inc.

^3. Dr. Joseph Capitano, P.E., is president of ARET. He has taught ESS methodology at the college level and to auto, industry, NATO, U.S., and European military manufacturers for more than 15 years. Dr. Capitano has undergraduate degrees in electrical technology and management and M.B.A. and Ph.D. degrees in management and logistics. He also has worked on the Defense Science Board and the Steering Committee for Quality and Reliability Assurance of the National Security Industrial Association and is a member of IES and the Management Committee of the Annual R&M Symposium.
ARET, 3203 Shadylawn Dr., Duarte, CA 91010, (626) 358-0933.