QUALITY MANUAL

1. QUALITY MANUAL Presented by: • Villa • Teresa • David • Vladimir

2. AGENDA • Introduction • Definitions • Quality • Quality System • Quality Manual • Brief history • Overview • Quality Manual • Elements of a Quality Manual • Advantages & Summary

4. What is quality? Quality is a series of characteristics of an element which make it capable of satisfying explicit and implicit requirements

5. Quality System The organization, structure, responsibilities, procedures, and resources, for ensuring the quality of a product or service. • The first step in building a Quality System is a Quality Manual.

6. What is a Quality Manual? • A Quality Manual is the main, top-level document which establishes the quality policies and objectives of an organization.

8. History • 18th century B.C. “if anyone give another silver, gold or anything else to keep, he shall show everything to some witness, draw up a contract and then hand it over for safe keeping.”

9. History • 1959 – quality system for U.S. Defence and aerospace industry was implemented • 1987 – ISO was established

10. What is ISO? • ISO produces international standards for business, government, and society. • The number one requirement is a: • Quality Manual

11. AGENDA • Introduction • Definitions • Quality • Quality System • Quality Manual • Brief history • Overview • Quality Manual • Elements of a Quality Manual • Advantages & Summary

12. What will a Quality Manual provide to a company? • Overall it provides evidence of what specific controls are implemented to ensure product/service quality. • Who will benefit ? • Customers • Suppliers • Employees The Company • ISO

14. A Quality Manual should…. • Address all Quality System elements • Contain or refer to quality procedures “Documentation”

15. The Importance of Documentation

16. Benefits of Documentation: Quality Manual • The Key is to move towards: • Consistently repeating the best practices and • Improving those processes which are lacking

17. 4 Levels of Documents

19. AGENDA • Introduction • Definitions • Quality • Quality System • Quality Manual • Brief history • Overview • Quality Manual • Elements of a Quality Manual • Advantages & Summary

20. So, what exactly do we find in a typical Quality Manual? You might just find things like…

21. Basic Quality Manual Outline • 1) Introduction • 2) Policy and Objectives • 3) Definitions • 4) Quality System • 5) Organization • 6) Authority and Responsibilities • 7) Compliance • 8) Internal Review and Audit • 9) Documentation and Change • 10) Purchasing • 11) Inspection and Testing • 12) Training

22. 1) Introduction • Who is the Company? • What does it do?

23. 2) Objectives • Why would anyone go to the trouble of assembling a Quality Manual anyway?

24. 3) Definitions • Maybe you already know exactly what ‘technotronic process management’ refers to, but in case you’re a little foggy…

25. 4) Quality System • How will we ensure that this company produces a quality product?

26. 5) Organization • Just use a chart for this one… Managing Director Financial Director Sales Director Admini-stration Credit control Support Manager Sales Manager Business Manager Purchase Ledger Ware-house Support Eng.

27. 6) Authority / Responsibilities • The various departments of a company, such as Sales, Engineering, Finance, etc… and what the people there are supposed to be doing.

28. 7) Compliance • Obviously, the company needs to stay in line with whatever governing body they’ve been certified by (ISO, etc…)

29. 8) Internal Review / Audit • Things SEEM to be rolling along nicely, but how would we really know if there was a problem? By waiting for our customers to tell us?

30. 9) Documentation and Change Control • Obviously, you can’t have people fiddling with important documents on a whim, but documents WILL need occasional updating, so…

31. 10) Purchasing • You want to produce a high-quality product, so do you REALLY want to do business with “Jethros baRgun SupPliz” because they’re cheap as borscht, or a fully certified and accredited company?

32. 11) Inspection and Testing • Your company may prefer to let its’ customers tell them that last shipment screwed up $150,000 worth of THEIR production, or…

33. 12) Training • Who knows? Maybe the company can readily find people who already know how to operate Zweiger Loopertronic TJ1453-A1F’s, but in case no one has a clue…

34. AGENDA • Introduction • Definitions • Quality • Quality System • Quality Manual • Brief history • Overview • Quality Manual • Elements of a Quality Manual • Advantages & Summary

35. Customizing your manual ?! • Meaning – to identify with which standards your company needs to comply. • Consider synchronizing your quality manual with the quality standards. YOU ARE DOOMMED IF YOU DID NOT COMPLY!

36. To prevent risks To detect deviations To correct errors To improve efficiency To reduce costs To meet customer needs To market company ADVANTAGES OF QUALITY MANUAL

37. SUMMARY • Introduction • Definitions • Quality • Quality System • Quality Manual • Brief history • Overview • Quality Manual • Elements of a Quality Manual • Advantages & Summary

39. References • www.bizmanualz.com • www.cartoonstock.com • www.Documents and Settings\Computer User\Desktop\presentation\Sample Quality Manual.htm • www.Documents and Settings\Computer User\Desktop\presentation\NIST Weights and Measures Division Quality Manual Template - Type Evaluation Laboratory.htm • www.Documents and Settings\Computer User\Desktop\presentation\ISO 10013 Quality Manual Development Guide in Plain English.htm • www.benitaepstein.com • www.Documents and Settings\Computer User\Desktop\presentation\dqs.htm • www.Earnest John Group of Companies.htm • Quality Systems, February, 12th 2003 GQO-PM/ SB Seminar Brazilian HA – Novartis (Global Quality Operations) • www.quality-works.com