Quality Management Systems

1. Quality Management Systems Its Elementary Chris P. James

2. Agenda • Elements of a Quality Management System • Product Realization • Continual Improvement • Resource Management • Affects on a FUS Standard • Questions

3. Quality Challenge Baldwin Corp. Scott Co. Wehr LLC. McArdle Services Colby Inc. Not Everything Is Always As It Appears

4. Elements of a Quality Management System “Quality is never an accident; it is always the result of high intention, sincere effort, intelligent direction and skillful execution; it represents the wise choice of many alternatives.” - William A. Foster

5. Elements of a Quality Management System • Organizational structure and Responsibilities • Process Controls and Methods • Data Management • Resources - including materials as well as human resources • Customer Satisfaction • Continuous Improvement (corrective/preventative action) • Product Quality (validation/verification) • Equipment Maintenance and Calibration • Sustainability - including efficient use of resources and responsible environmental operations • Monitoring by continual assessment (internal or external)

6. What Can a Quality System Manage • Production System • Packaging & Labeling System • Facilities & Equipment System • Laboratory Controls System

7. Which Path is Acceptable? ACME Quality Manufacturer’s Quality Program

8. Product Realization “Quality is not an act, it is a habit.” - Aristotle

9. What should a quality system manage Product Realization is the combination of all processes (step by step) - from initial design to actual delivery of final product/service - that deliver an output meeting defined requirements (specifications).

10. Continual Improvement “Quality means doing it right when no one is looking.” – Henry Ford

11. Continual Improvement 1. Containment 2. Root Cause Analysis 3. Corrective Action 4. Preventative Action

12. Continual Improvement Containment: Immediate actions to reduce the severity of the identified problem (slow production line, provide for temporary fix/repair, etc.)

13. Continual Improvement Root Cause Analysis: A detailed review of the issue to determine the true cause for the problem. Utilizing various methods such as 5 why’s, Ishikawa (fishbone/cause-effect) chart, etc.

14. Continual Improvement Corrective Action: Once the true cause of the problem is identified, action take to resolve/reduce the likely of same problem from reoccurring.

15. Continual Improvement Preventative Action: Analysis of processes/operations to mistake proof them so as to eliminate problems from happening (prevention)  

16. Resource Management “The quality of an organization can never exceed the quality of the minds that make it up.” - Anonymous

17. Personnel Competency and Development Personnel competency can be broken down into the following areas: • Determine the necessary competence (skills) • Provide training and evaluate the effectiveness • Ensure that personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives. • Maintain appropriate records of education, training, skills and experience.

18. Elements That Can Be Overlooked • The working environment should also be managed to help achieve a conforming product, such as: • Human factors: • safety rules and guidance • ergonomics • Physical factors: • hygiene, cleanliness • noise, vibration • heat, light, air-flow • security

19. Affects on a FUS Standard “It is easier to do a job right than to explain why you didn't” - Martin Van Buren

26. Questions Steve Schmid, ASQ CMQ/OE Quality Assurance Director Steven.J.Schmid@ul.com 919-549-1846