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Omnexsystem spresentation
Omnexsystem spresentation
Omnexsystem spresentation
Omnexsystem spresentation
Omnexsystem spresentation
Omnexsystem spresentation
Omnexsystem spresentation
Omnexsystem spresentation
Omnexsystem spresentation
Omnexsystem spresentation
Omnexsystem spresentation
Omnexsystem spresentation
Omnexsystem spresentation
Omnexsystem spresentation
Omnexsystem spresentation
Omnexsystem spresentation
Omnexsystem spresentation
Omnexsystem spresentation
Omnexsystem spresentation
Omnexsystem spresentation
Omnexsystem spresentation
Omnexsystem spresentation
Omnexsystem spresentation
Omnexsystem spresentation
Omnexsystem spresentation
Omnexsystem spresentation
Omnexsystem spresentation
Omnexsystem spresentation
Omnexsystem spresentation
Omnexsystem spresentation
Omnexsystem spresentation
Omnexsystem spresentation
Omnexsystem spresentation
Omnexsystem spresentation
Omnexsystem spresentation
Omnexsystem spresentation
Omnexsystem spresentation
Omnexsystem spresentation
Omnexsystem spresentation
Omnexsystem spresentation
Omnexsystem spresentation
Omnexsystem spresentation
Omnexsystem spresentation
Omnexsystem spresentation
Omnexsystem spresentation
Omnexsystem spresentation
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Omnexsystem spresentation
Omnexsystem spresentation
Omnexsystem spresentation
Omnexsystem spresentation
Omnexsystem spresentation
Omnexsystem spresentation
Omnexsystem spresentation
Omnexsystem spresentation
Omnexsystem spresentation
Omnexsystem spresentation
Omnexsystem spresentation
Omnexsystem spresentation
Omnexsystem spresentation
Omnexsystem spresentation
Omnexsystem spresentation
Omnexsystem spresentation
Omnexsystem spresentation
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Omnexsystem spresentation
Omnexsystem spresentation
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Omnexsystem spresentation

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    • 1. Omnex Systems ISO 9000:2000 EwQMS ®
    • 2. Contents
      • About Omnex
      • ISO 9001:2000 and EwQMS ® Strategies for QS-9000 and TS-16949
      • Closer Look at The Software
        • Doc Pro
        • BOSS
        • Audit Pro
        • MSA Pro
        • AQuA
      • Why EwQMS ®
    • 3. About Omnex
    • 4. Driving Worldwide Business Excellence
    • 5. Venezuela- Carabobo
      • Brazil-
      • San Paulo
      Core Competence Global         QS-9000 Service Semiconductor US 3 Offices Canada Philippines China 3 Offices Mexico Thailand- Bangkok India- Chennai Germany- Gosheim UK- England ISO 9001:2000 TE Supplement ISO 14000 ISO/TS 16949
    • 6. OMNEX Methodologies
      • TS 16949
      • ISO 9001:2000
      • QS-9000
      • ISO-14000
      Lead Auditor Internal Auditor Value Added QOS APQP PAP FMEA/Control Plan Standards Auditing New Product Development Management Tools SPC DOE Lean Manufacturing
      • Team Based
      • How To
      • Excellence Based
      • Hands On
    • 7. Enterprisewide Quality Management System Suite (EwQMS ®)
    • 8. Enterprisewide Quality Management System Suite (EwQMS ®)
    • 9. About AQSR
      • ISO 9001:2000
      • TS 16949
      • QS-9000
      • TE Supplement
      • AS 9000
      • Improvement Based
      • Experienced
      • Customized
      a management systems registrar providing accredited third party registration/certification to the ISO 9000, QS 9000, TE Supplement, VDA 6.1 and ISO 14000 series of international standards
    • 10. Offices World Wide
      • OMNEX US 3 offices Mexico China Brazil Thailand India
      OMNEX Systems US India AQSR US Canada China 2 offices Germany Mexico Taiwan UK Venezuela
    • 11. Customer Awards
      • India
        • FORD India
        • Maruti Udyog (Suzuki)
        • TELCO
        • CII - Governmental Advisory Board
        • TISCO (Tata Steel)
      United States & Canada - TS16949 Rollout Voted top five US Registrar by Quality Digest Lucent -Delphi -Visteon -Magna Latin America -Ford Mexico -Corn Products -Venezuela Automotive Industries
      • Taiwan/China
        • Good Year
        • DFM Motors
        • Clarion
        • Mitsubishi Dealerships (34)
      Thailand - ISUZU Engines -Thai Bridgestone -Sony Semiconductor -AMD -3M -NSK -Matsushita
    • 12. What Customers Want Excellence Global Solutions Customized Solutions Human Interaction
    • 13. Company with a Unique Global Vision
      • Performance with Excellence
      • Growing Big and Staying Small
    • 14. ISO 9001:2000 and EwQMS ®
    • 15. QMS Process Model
      • How does this model work?
      PLAN PLAN CHECK/ ACT DO
    • 16. Process Model and ISO 9001:2000 Clause Headings
      • Quality Management System 4.0
      • Management Responsibility 5.0
      • Resource Management 6.0
      • Product Realization 7.0
      • Measurement, Analysis, Improvement 8.0
      ISO 9001:2000 Clauses ISO 9001:2000 clauses are integrated and linked
    • 17. 4.0 Quality Management System 4.1 General Requirements 4.2 Documentation Requirements
    • 18. 4.0 Quality Management System
      • 4.1 General Requirements
      • 4.2 Documentation Requirements
      • Requirements for Processes - Process Mapping, Process Flow, Monitoring (trend chart) and Continual Improvement (Teams and Improvement Proposals)- This is satisfied by Process Pro and BOSs
      • Documentation Requirements and Document Control is satisfied by Doc Pro.
    • 19. 5.0 Management Responsibility 5.1 Management Commitment 5.2 Customer Focus 5.3 Quality Policy 5.4 Planning 5.5 Administration 5.6 Management Review
    • 20. 5.0 Management Responsibility
      • 5.3 Quality Policy - Doc Pro
      • 5.4 Planning - Objectives/Deployed Objectives and Improvement Proposal and Proposal Ratings - BOSS
      • 5.5 Administration - See next page
      • 5.6 Management Review - BOSS
      • 5.1 Management Commitment- Evidence in Doc Pro (Quality Policy) and BOSS of their involvement in Management Review and in setting objectives and providing resources
      • 5.2 Customer Focus - Customer Expectations gathering and evidence of meeting them - BOSS
    • 21. 5.5 Administration
      • 5.5.1 Responsibility and authority- Organizational chart and job responsibilities - Doc Pro
      • 5.5.2 Management Representative - evidence in BOSS and Doc Pro and other
      • 5.5.3 Internal Communication- Web access of Management Review and Internal audits and e-mails
    • 22. 6.0 Resource Management 6.1 Provision of Resources 6.2 Human resources 6.3 Facilities 6.4 Work environment
    • 23. 6.0 Resource Management
      • 6.1 Provision of Resources - Improvement Proposal rating form, Management Review minutes, and resource planning document in Doc Pro
      • 6.2 Human resources - Currently, can be designed in Excel. New software will be designed by 3rd quarter- 2001
      • 6.3 Facilities - Data analysis and meeting showing no facilities problem - BOSS
      • 6.4 Work environment - Data analysis and meeting showing no work environment problem - BOSS
    • 24. 7.0 Product Realization
      • 7.1 Planning of Realization Processes
      • 7.2 Customer-Related Processes
      • 7.3 Design and/or Development
      • 7.4 Purchasing
      • 7.5 Production and Service Operations
      • 7.6 Control of Measuring and Monitoring Devices
    • 25. 7.0 Product Realization
      • 7.1 Planning of Realization Processes - Process Map in Process Pro and documentation of processes. held in Doc Pro. Quality Plan can be held in AQuA
      • 7.2 Customer-Related Processes- Customer expectations of product in BOSS, Requirements (Contract) Review form in Doc Pro, and custom designed intranet and database
      • 7.3 Design and/or Development - AQuA can be used as/is or simplified to work with ISO 9001:2000
      • 7.4 Purchasing - New software to be designed for supplier development by beginning of 3rd quarter.
      • 7.5 Production and Service Operations- See next page
      • 7.6 Control of Measuring and Monitoring Devices - MSA Pro; Note: the calibration module may be sufficient
    • 26. 7.5 Production and Service Operations
      • 7.5.1 Operations Control - AQuA Standardization Module with control plan
      • 7.5.2 Validation of Processes - PPAP or equivalent and capability studies of the process. Need to integrate with SPC package
      • 7.5.3 Identification and Traceability - Procedure in Doc Pro
      • 7.5.4 Customer Property- Procedure in Doc Pro
      • 7.5.5 Preservation of Product - Procedure in Doc Pro
    • 27. Prepare a Key Process Map
    • 28. 8.0 Measurement, Analysis, and Improvement
      • 8.1 General Planning
      • 8.2 Measurement and monitoring
      • 8.3 Control of nonconformity
      • 8.4 Analysis of data
      • 8.5 Improvement
    • 29. 8.0 Measurement, Analysis, and Improvement
      • 8.1 General Planning - Evidence of measurement planning in BOSS, Process Pro and AQuA
      • 8.2 Measurement and monitoring- Customer Satisfaction measurement in BOSS, questionnaire in Doc Pro, Internal Audit in Audit Pro, Process and Product Measurements in BOSS.
      • 8.3 Control of nonconformity - BOSS Datasheet and Chart and process in Doc Pro
      • 8.4 Analysis of data - Data in BOSS and team meeting
      • 8.5 Improvement - Data in Boss and Team Meeting including Management Review, Corrective Action (8-D) in BOSS and Aqua.
    • 30. EwQMS ® and QS-9000/TS-16949
    • 31. EwQMS ® and QS-9000 /TS-16949
      • TS-16949 is the standard of the future and is the only standard that is going to be revised to meet ISO 9001:2000 requirements
      • TS16949 second edition is currently slated to be completed by first or second quarter 2002
      • Companies currently QS-9000 or implementing TS-16949 should incorporate ISO 9001:2000 in their implementation
      The Omnex Pro-Suite 2000 has already considered the next edition of TS-16949 and is designed to incorporate both TS-16949:99 and ISO 9001:2000
    • 32. A Closer Look at the Software
        • Document Pro , BOSS, Audit Pro, MSA Pro
    • 33. Document Pro
    • 34. Document Pro
      • Software that documents the organization’s Quality Management System (QMS) in one level up to eight levels. Typically it is - level one - Quality Manual, level two - Procedures, level three - Work instructions, level four - Forms and Checklists
      • Gateway to other Software Packages - BOSS, Process Pro, Audit Pro, MSA Pro, AQuA-Process Analyzer
      • Manages change of all documentation including documentation in Process Pro and AQuA
    • 35. How Document Pro Works
      • Security - Persons signing on can see documents, read, or request a change
      • The user will be asked the level of documents that they want to open - quality manual, procedure, work instruction or form/checklist
      • The user can select the level and it will open to a table of contents
        • The user can double click the document of choice
        • The table of contents is also the master list and shows the latest revision level of all company documents
    • 36. Navigator Bar
      • Action will list all the actions that the user has to take
      • Access to levels of documents
      • Modify personal information
      • Create a Document Change Request
    • 37. How Document Pro Works
      • The open document will show all the related documents, revision history, and personal “actions” on the left side
        • The related documents can immediately be accessed by selection from this screen
        • The revision history of the document can also be viewed
    • 38. Doc Pro - Administrator
      • The administrator sets up all users and their security levels
      • Setting up documents the first time -
        • Users will need to request for new documentation upload
        • New documents will follow approval process
    • 39. Change Request
      • The Change Request has to be set up for all new documents and for changes to documents
      • Change requests can be routed within the organizational hierarchy
        • The route indicates serial and parallel steps for a changed document.Standard routes can be set up for classes of documents
    • 40. Change Request Management
      • Both the administrator and the requestor can track status of change levels
        • The software will automatically send messages as the document moves along the route
      • Administrator
      • User
    • 41. BOSS
    • 42. BOSS Software Functionality
      • BOSS software allows companies to align customer expectations to key processes to improvements
      • Also, it facilitates data gathering and viewing of company key measurable and process measurable
      • It allows management of Management Reviews and improvement team meetings
    • 43. Customer Expectations to Improvement Alignment
      • Steering Committee of the top management in the company can be formed
      • Subsequent departmental committees at other levels in the company can also be formed
        • Departments can track and improve deployed measurables from top management
          • These are called aggregation levels - data collection must use forethought to their future use
    • 44. Gathering Customer Expectations
      • Customer expectations are gathered and entered two ways -
        • It can be entered via table driven entries
        • It also can be entered via post-it notes
          • Both the expectation and the customers are entered
          • The expectations can be moved to group them under an expectation category
    • 45. Benchmarking
      • Customer expectation categories are benchmarked against the competition and best in class companies
      • The benchmarking information is used to help form short and long term objectives
    • 46. Alignment Chart
      • The expectation category and the expectations are used to identify
        • Result measurables that measure the expectation category
        • Key Processes of the expectation category. The key processes directly impact the expectation
        • Process measurable that measure the key process
      • Improving the process measurable helps to improve the result measurable which then results in meeting customer expectations
    • 47. Improvement Proposals
      • Improvement Proposals are formed to close the gap between the as-is and the Goal Line
      • The improvement Proposal identifies the projects to be taken, benefits and costs of the program. BOSS provides automatic rating of proposals by management teams for resource allocation.
      • The improvement proposals can be placed in the alignment chart indicating that it is a proposal for a particular customer expectation category. In this manner, all improvements are focused on meeting customer expectations
    • 48. Data Entry and Visual Analysis
      • Data entry can be directly into BOSS or can be programmed by Omnex for automatic entry
      • Charts with constant or variable goals can be easily accessed
        • A special feature of Boss is the link between data and aggregation levels. The chart has a special drill down feature that allows the user to click down to the root cause. For instance Overall downtime can be clicked to Departmental downtime and then clicked to Machine downtime. Furthermore, each chart can be saved for team or Steering Committee meetings.
      • Departmental charts - ie aggregation levels
      • Pareto charts and identification of problems
      • Charts and paretos can be saved for management review and improvement team meetings
    • 49. Management Review and Improvement Meetings
      • Management Review
        • Creating Agenda and presentations
        • Linking charts to presentations
        • Writing meeting minutes
        • Creating Action Plans
      • Improvement Teams
        • Creating Agenda and presentations
        • Linking charts to presentations
        • Writing meeting minutes
        • Creating Action Plans
      Any type of meeting can be housed within BOSS
    • 50. Audit Pro
    • 51. About Audit Pro
      • Audit Pro can manage,schedule, assign and check status of audits and corrective actions for
        • Internal audits
        • Third Party audits
        • Single organizations
        • Multiple organizations
      • Audit Pro can manage hundreds of audit of any number of audit programs including ISO 9000, QS-9000, ISO 14000, Housekeeping and Safety, Environmental compliance audits simultaneously for multiple or single plants.
    • 52. Audit Types and Audit Forms
      • Audit Programs can have entities called Audit types which are - System, Product or Process audits or Document review, pre-audit or surveillance..
      • The Program will allow the user to use the same or different forms for each audit program and type
    • 53. Audit Pro
      • Assign Auditors who are then automatically notified of the assignment via e-mail
      • Schedules and manages audits
        • The audit schedule has a color code that will indicate an audit waiting to happen (orange), audit that did not occur (red) or an audit that took place on time and paperwork submitted (green)
    • 54. Auditor Sign Up
      • Auditors Sign On and are only authorized to view audits assigned to them
      • Down load forms for an audit
      • Upload forms after the audit is complete, this signifies the completion of an audit and changes the orange status to a green
      • Assign Corrective Actions (non-conformances)
    • 55. How Corrective Action Works
      • Three steps - write non-conformance, auditee responds, auditor closes it out
      • Audit Pro will track each corrective action by number and three actions as follows:
        • Auditor attaches the corrective action - overall audit turns from orange to green
        • Auditee responds and auditor attaches the replies
        • Auditor attaches the close out
      • All events are controlled and monitored with event deadlines for corrective action. It will also send e-mails to all parties concerned
    • 56. Providing Access to Client/Auditee
      • Auditor decides what forms to provide client/auditee
      • Provide Customer sign on access
      • Client/auditee down loads documents, complete them and e-mails them back to auditor
      • Client/auditee can view forms as authorized, before and after an audit
    • 57. MSA Pro
    • 58. MSA Pro
      • Organizations have inspection, testing, and lab equipment that need to be
        • Identified and Cataloged
        • Calibrated
        • Measurement Uncertainty Studied
        • Manages Gage Program
    • 59. Identification and Cataloged
      • Families are created
      • Measurement instruments are assigned to Families
      • Measurement instruments are cataloged
    • 60. Calibration of Instruments
      • Calibration is conducted using internal or external labs
      • MSA-Pro requires traceability of masters to NIST
      • Calibration will automatically calculate bias and linearity
    • 61. Measurement System Analysis
      • Measurement System Analysis studies are created for families and characteristics
      • Each gage is attached to a family or families for
        • Bias
        • Linearity
        • Stability
        • Gage R and R
    • 62. Measurement System Analysis (MSA)
      • Gage R& R will show the repeatability and reproducibility of a gage
      • Bias can be calculated when a calibration is done or can be studied separately
      • Multiple Bias studies will give the result for linearity and can be graphed
      • Stability can be studied by graphing multiple calibrations or studied separately
    • 63. Available Reports and Graphs
      • Many reports and graphs are included in MSA Pro
    • 64. AQuA 3
    • 65. AQuA 3
      • Manages Process and Quality Documentation
      • A process review tool
      • A vehicle for continual improvement
    • 66. How AQUA uses data, documents and tables
      • Data
        • Relational Database, not in the Documents
      • Document
        • Document always reflects the latest changes
      • Table
        • Maintains consistency
    • 67. AQuA Structure
    • 68. How AQUA uses branching
    • 69. How AQUA links documents?
      • Data linkage
        • Automatically updated data
      • Format linkage
        • Documents have a uniform and consistent appearance
    • 70. AQuA Feature List
      • Create your own format
      • AQuA Default format
      • View Design & Print Design
      • Copy an existing Part to a New Part
      • Hiding Branches
      • Freezing Columns
    • 71. AQuA Feature List
      • Customize header, trailer, first page header, first page footer, last page footer
      • Customize column heading in Documents
      • Copy, cut and paste cell contents
      • Indenting and Outdenting
    • 72. Advanced Features
      • Templates
      • Process List
      • Document Revision Control by Using AQuAView
    • 73. Additional/Optional Modules
      • Standardization Module
      • Production Part Approval Process Module (PPAP)
      • 8-D Reports
    • 74. Security Features
      • User ID and Password
      • Restricted Access to Specific Features
      • Restricted Access to Specific Documents
      • Restricted Access to Parts/Part Families and Documents
      • Group Access Vs Individual User Access
    • 75. Why Omnex Pro-Suite
    • 76. Annual savings from ISO 9000
        • Savings for Companies with Sales:
          • Greater than $200 million - $443,701
          • $25 million to $200 million - $109,890
          • less than $25 million - $53,895
      • Source: ISO 9000 Survey ‘99, McGraw-Hill
    • 77. Costs of ISO/QS 9000
      • Costs for Companies with Sales:
          • Greater than $200 million - $299,765
          • $25 million to $200 million - $106,890
          • less than $25 million - $72,502
      • Source: ISO 9000 Survey ‘99, McGraw-Hill
    • 78. Cost savings using software
        • Software helps in
          • Customization - Customize programs for use
          • Routinization - Putting into daily practice
          • Best Practices - Improve savings by a factor of 33%
      • Source: ISO 9000 Survey ‘99, McGraw-Hill
    • 79. Overall software savings
        • Software Savings for Companies with Sales
          • Greater than $200 million - $296,190
          • $25 million to $200 million - $86,970
          • Less than $25 million - $53,490
      • Source: ISO 9000 Survey ‘99, McGraw-Hill
    • 80. Software removes reported road blocks
        • Road Blocks to maintaining ISO/QS 9000
          • Employee Resistance - Software makes it easy and creates routinization
          • Document Maintenance - Document Pro
          • Training Requirement - Omnex provides software and training
          • Calibrating Instruments/Equipment - MSA Pro
          • Management & Commitment - BOSS and Executive Training from Omnex
          • Not Following Procedure - Document Pro, Process Pro, Audit Pro
          • High Cost - Software saves money
      • Source: ISO 9000 Survey ‘99, McGraw-Hill

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