1. Stephanie Sheesley, B.S., RAC DENTSPLY International

2. “Building Quality”

3. 28. QC-Quality Control: In-Process checks/testing to uncover defects. 28. QA-Quality Assurance: Final Product Release—”fit for purpose”. Also key for identifying preventative actions. 28. RA-Regulatory Affairs: Liaison between Mfg and Consumer. Ensures products are safe and effective.

9. Aeronautics and Space Postal Service Highways Agriculture Banks and Banking The President of USA …and the list goes on!!!

11. 28. Total Quality Management (TQM): Controlling quality within all functions of a business from new product development to release of commercial product…from the CEO to the assembly line…in order to identify and reduce/eliminate undesirable effects (defects). The cause of an undesirable effect (defect) can be grouped into one of six categories…

12. #1: PEOPLE Qualified/Trained individuals involved in any part of the process.

13. #2: METHODS How the process is performed and the specific requirements for doing it, such as policies, procedures, rules, regulations and laws.

14. #3: MACHINES Any equipment, computers, tools, etc. required to accomplish the job.

15. #4: MATERIALS Raw materials, parts, pens, paper, etc. used to produce the final product.

16. #5: MEASUREMENTS Data generated from the process that are used to evaluate quality.

17. #6: ENVIRONMENT The conditions, such as location, time, temperature, and culture in which the process operates.

18. Ishikawa Diagram (fishbone, cause/effect)

20. Sources of Feedback:  Customers/Complaints  Recalls  Internal/External Audits  Personnel

21. TQM + Feedback = CIP (Continuous Improvement Process)

23. 28. What is Continuous Improvement Process (CIP)? An ongoing effort to improve products, processes, or services through: Feedback: the reflection of processes. Efficiency: the identification, reduction, and elimination of suboptimal processes. Evolution: using incremental, continuous steps rather than giant leaps.

26. 28. Six Sigma

27. 28. Lean Manufacturing/Business/ New Product Development

28. 28. Kaizen Events

29. 28. Poka Yoke “Fail-Safing”/”Mistake Proofing” Yoke-Avoid Poka-Mistakes

30. 28. 5 Whys Define the problem. Then ask: 1. Why? 2. Why? 3. Why? 4. Why? 5. Why?

32.  Reworks  Recalls  Litigations  FDA Enforcement  Loss of Credibility with Regulatory Agencies (FDA)  Loss of employee morale  Negative effect on product approvals and stock price.

33. Compromising your integrity leads to poor quality and ultimately an irreverent reputation…invest in truth and success will abound.