By having your document control and shop floor quality control systems tied together at the data level, this assures all your quality efforts are operating under the same best practices and use the same data. No problems will be caused due to duplication of effort or data errors. And by having one set of master data - including ERP - you can operate fully within your QMS guidelines. Read full description of this webinar on the IBS America, Inc. Blog: http://info.ibs-us.com/blog/bid/37826/Webinar-How-to-Merge-Document-Control-and-Shop-Floor-Quality-Control

1. IBS: Unified Document Control and Shop Floor Quality Control August 2011 IBS America T H E P R O D U C T I V I T Y A D V A N T A G E

2. Agenda The Case for Unified Quality CompliantPro QSYS IBS Question and Answer

4. Why do you need both?

5. How do they work together?

6. What kinds of functionality do they provide?

7. How does it support Your Business Initiatives?© IBS AG Slide 3

9. Customers

12. Compliance ISO / Gov. / Regulating Body

13. Real Time Inspections and Analysis

14. Advanced Quality Planning/FMEA

15. Complaint Management

16. Scheduling and Execution Management

17. Training Management

18. Corrective Action Management

19. Calibration Management

20. Laboratory Management

21. Plan – Do – Check – Act © IBS AG Slide 5

22. How Do We Support the Organizations Initiatives? Quality Systems act like levers to reduce cost Higher Quality = Higher Market Share Compliance To Standards Records, Controls Schedules, Training and Verifiable Proof © IBS AG Slide 6

24. Increase productivity

25. Reduce scrap and rework

26. Lower Costs

27. Establish Plans, Controls and Train

28. ISO & Governmental© IBS AG Slide 7

30. Efficiency

31. Know How

32. Safety

33. Input / Feedback

34. Work Instructions

35. Expertise/Training Profile

36. Best Practices

37. Videos / Graphics / Pictures

38. Handling and Safety Info, especially in case of an incident

41. Design and Plan for reliability, quality $$$$

42. Verify Supplier Quality

43. Monitor Production Quality

44. Use Proven Improvement Processes Continuously:

45. SPC

46. CAPA

47. FMEA

48. PDCA© IBS AG Slide 10

49. IBS Quality ManagementSolution: PDCA-cycle Action Management FMEA Control Plan Flowchart Project Management Problem Solving Process Audit Management Inspection Planning Incoming Goods SPC Production Quality Control Panel Supplier Assessment Outgoing Goods

50. IBS Quality Execution ManagementSolution: PDCA-cycle Action Management Order Management Resource Planning Problem Solving Process Audit Management Fine planning Process Overview / Online-Visualization Paperless Repair KPI (OEE, FPY) Analysing (PAA, CPK) MDA ODA © IBS AG Slide 12

51. IBS Traceability solutions for product and process traceability Purchased Parts Transport Traceability KPI‘s Cockpit Standard Components Standard Assembly Groups © IBS AG Slide 13

52. CompliantPro at-a-Glance CAPA FDA Compliance CAPA FDA Compliance Training & Qualifications Enterprise Risk Management Training & Qualifications Risk Management & SOX Audits & Assessments Document Management Environmental Health & Safety Document Management Health & Safety Supplier Management Supplier Management Environmental Customer Management Inspection Management , Nonconformance, & SPC Customer Management APQP (FMEA/Control Plan/PPAP) Prüfmittel- management Equipment Maintenance & Calibration Reporting Prüfmittel- management Equipment Maintenance & Calibration

54. Document Templates for each Category

55. List of who can create Documents

56. Document Numbering Scheme

57. Review, Approval and Obsolescence Workflows

58. Management Escalation Procedure

59. Document Release Date

61. Links to updated documents and changing course requirements.

62. Advises of any missed deadlines.

63. Alerts manager when employees are deficient/ create list.

64. Meets regulatory requirements for monitoring employee qualifications.

65. Prevents oversights.

66. Automates the monitoring function.

67. Prevents assignment of unqualified employees

69. Slide 18 Corrective Actions & Preventive Actions Modules

71. Allow a leader to assign a “team” to manage Containment and Resolution responses.

72. Elect to follow an “8D” or “7Step” procedure model, or Configure your own specific workflow for CAR resolution.

75. Agenda Agenda and Introduction Customer Case Studies / Benefit Analysis Solution Overview Company Overview Questions?

78. Revenue 2008: ~ $30 million

79. Founded in 1982

80. Today about 180 employees

82. Implementation

83. Training

84. Project ManagementDirectors MIS ERP MES Company mgmt. Process control Data flow Machine control Production Maintenance Operation Implementation

85. IBS Customers Save Money The Cost of Quality as % of Revenue Source: Aberdeen Group 2009 IBS customers achieve substantial cost reductions with better than average performance (e.g. first pass yields, on time shipments).

86. Agenda Agenda and Introduction Customer Case Studies / Benefit Analysis Solution Overview Company Overview Questions?

87. Thank You! “Merging Document Control with Shop Floor Quality Control” Presenter: Tim Gamble Email: tim.gamble@ibs-ag.com Phone: 1 (781)-862-9002 x137 Read the IBS Blog for more quality resources, whitepapers, articles, and webinars: www.info.ibs-us.com Follow Us on Twitter: @IBSAmerica