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' Qual·i·ty·'ol·o·gy n: the study of excellence

Stephanie Sheesley, B.S., RAC DENTSPLY International. ' Qual·i·ty·'ol·o·gy n: the study of excellence. Case Study. “Building Quality”. QC? QA? RA?...Huh?. 28. QC-Quality Control : In-Process checks/testing to uncover defects. 28. QA-Quality Assurance :

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' Qual·i·ty·'ol·o·gy n: the study of excellence

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  1. Stephanie Sheesley, B.S., RAC DENTSPLY International 'Qual·i·ty·'ol·o·gyn: the study of excellence

  2. Case Study “Building Quality”

  3. QC? QA? RA?...Huh? 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.

  4. Regulated Industries

  5. Food & Beverages

  6. Education

  7. Pharmaceuticals

  8. Medical Devices

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

  10. 48. Total Quality Management (TQM)

  11. What is TQM? 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. The Six Causes of Defects #1: PEOPLE Qualified/Trained individuals involved in any part of the process.

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

  14. The Six Causes of Defects cont. #3: MACHINES Any equipment, computers, tools, etc. required to accomplish the job.

  15. The Six Causes of Defects cont. #4: MATERIALS Raw materials, parts, pens, paper, etc. used to produce the final product.

  16. The Six Causes of Defects cont. #5: MEASUREMENTS Data generated from the process that are used to evaluate quality.

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

  18. The Six Causes of Defects cont. Ishikawa Diagram (fishbone, cause/effect)

  19. TQM + Feedback

  20. TQM + Feedback Sources of Feedback: • Customers/Complaints • Recalls • Internal/External Audits • Personnel

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

  22. 28. Continuous Improvement Process (CIP)

  23. Continuous Improvement Process 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.

  24. Continuous Improvement Process cont.

  25. TQM & CIP Methodologies

  26. TQM & CIP Methodologies 28. Six Sigma

  27. TQM & CIP Methodologies cont. 28. Lean Manufacturing/Business/ New Product Development

  28. TQM & CIP Methodologies cont. 28. Kaizen Events

  29. TQM & CIP Methodologies cont. 28. Poka Yoke “Fail-Safing”/”Mistake Proofing” Yoke-Avoid Poka-Mistakes

  30. TQM & CIP Methodologies cont. 28. 5 Whys Define the problem. Then ask: • Why? • Why? • Why? • Why? • Why?

  31. Cost of Quality

  32. 28. Cost of Quality • 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. Integrity = Quality = Excellence Compromising your integrity leads to poor quality and ultimately an irreverent reputation…invest in truth and success will abound.

  34. Best of Luck Class of 2013!!

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