The Medical Device Industry
                       •   Projected  $133 B 2016
                       •  More than 6,500 companies
                       •  80% less than 50 people
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                      The Case for Quality
                                         Began the dialogue: 
                                         • Focus on Compliance vs 
                                           Product Quality
                                         • Measurement and 
                                           Transparency
                                         • Culture
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                      The Case for Quality
            “ the regulation does not prescribe in detail how a 
         manufacturer must produce a specific device. Rather, the 
     regulation provides the framework that all manufacturers must 
          follow by requiring that manufacturers develop and follow 
                      procedures and fill in the details”
                     The Regulations Provide the “What”
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                     The “WHAT” of CAPA
     PART 820.100  - Corrective and Preventive action: 
     • Establish and maintain procedures… 
     • Investigating the cause of nonconformities…
     • Identifying the action needed…
     • Verifying or validating the action …
     • Implementing and recording changes ……
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                      The “HOW” of CAPA
     • Containment and Interim Corrective Action
     • Problem Solving - DMAIC,  8D, 5 Whys, Fishbone 
       diagrams 
     • Project Management
     • Metrics
     • Culture - Reward and Recognition
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