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.
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.
The opinions expressed in this article are those of the author only and do not represent the views of the Techman/Kanata or of any of its directors, officers or employees. The author, Peter Philips, can be reached at firstname.lastname@example.org
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Peter Philips, MSEE, January 2008