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      Chapter

      Preventing Recalls Using a Verification Process
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      Chapter

      Preventing Recalls Using a Verification Process

      DOI link for Preventing Recalls Using a Verification Process

      Preventing Recalls Using a Verification Process book

      Preventing Recalls Using a Verification Process

      DOI link for Preventing Recalls Using a Verification Process

      Preventing Recalls Using a Verification Process book

      ByDev Raheja
      BookPreventing Medical Device Recalls

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      Edition 1st Edition
      First Published 2014
      Imprint CRC Press
      Pages 8
      eBook ISBN 9780429254239
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      ABSTRACT

      Many companies have a so-called final design review. Some call it the critical design review. This is the last chance to determine if anyone is concerned about anything in the design. Always remember: Learn to say “no” to yes-men. If the final design is presented and everyone votes “yes” and approves the design, then your answer should be “no.” Why? Because there are almost always new problems lingering in the minds of the team members, but they don’t speak because they think it is too late to interfere. If no one is challenging the design, the device is bound to crash in use, unless the device is very simple. No matter how good the design is, an independent facilitator can find many issues with it. Ford Motor Company hired a new vice president during the design of the 1995 model of the Lincoln Continental. The company had been making this car for years and everyone on the team had at least 10 years of experience. The design was already approved, but the new vice president insisted on questioning every detail of the design with a crossfunctional team made up of engineers from each subsystem. He included a marketing manager and service engineers. They made over 700 changes in the design! Since they made these improvements before the design was in manufacturing, they saved $60 million (the potential cost of making engineering changes in production, rework, and reducing the number of inspectors). The new product was released 4 months ahead of schedule!

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