This Quality compliance training will helps in methodologies of Six Sigma and CAPA converging and how to recognize which methodology is best to use for a problem.
Simply documenting "it broke - I fixed it" does very little to instill permanent solutions. Six Sigma methodology is an ideal toolbox for drilling into the root causes of problems and making certain that permanent solutions are in place. The true spirit of CAPA and Six Sigma is the improvement fo the overall system and the reduction in variation around a previously established "centered" process. Too many companies focus on the speed with which CAPAs are closed, yet pay too little attention to the effectiveness and longevity of the solution.
Areas Covered in the Session:
- Why are the methodologies of Six Sigma and CAPA converging?
- How to recognize which methodology is best to use for a problem.
- How should my quality systems work together?
- Best Practices
- Should Electronic Signatures apply to my Enterprise Six Sigma system?
Who Will Benefit
- Quality System Managers
- Operation Managers
- Engineering Managers
- Other similar quality, operations
- and engineering personnel
Instructor Profile
Jose Mora is a Sr. Consultant at Streale as well as a partner in Atzari Consulting, LLC. Although he has been in the medical device industry for 24+ years in various companies, he has observed that the same types of issues and principles apply in all cases. Jose has worked as a Director of Manufacturing, Director of Manufacturing Engineering, Sr. Manufacturing Engineer, and as a Quality Systems Manager at companies such as V. Mueller (Cardinal Health), Cordis Corporation (J&J), Mentor Corporation, UroSurge (a startup urology products company), Boston Scientific, as well as several consulting clients. Jose has a BS. in Mechanical Technology from Purdue University.
