Iso 9000 2000 Audits


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Iso 9000 2000 Audits

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  • Iso 9000 2000 Audits

    1. 1. ISO 9000:2000 Internal Audits BY: Ahmad Bassiouny Evelean William
    2. 2. Overview: ISO 9000:2000 Internal Audit <ul><li>ISO Audit Requirements </li></ul><ul><li>Getting Started </li></ul><ul><li>Steps to an effective audit </li></ul><ul><ul><li>Planning </li></ul></ul><ul><ul><li>Execution </li></ul></ul><ul><ul><li>Follow up </li></ul></ul><ul><li>Cessna’s Approach </li></ul>
    3. 3. ISO 9000 Audit Requirements <ul><li>Internal audits are required (4.17) </li></ul><ul><li>Must be conducted by personnel independent of responsibility for process being audited </li></ul><ul><li>Results must be recorded </li></ul><ul><li>Must follow organizational objectives </li></ul><ul><li>Frequency should be determined by the organizational need </li></ul>
    4. 4. Defined: <ul><li>An ISO 9000:2000 internal audit is a method for verifying the efficiency and performance of an organizations quality system. It ensures that the quality system meets or exceeds the required standard for certification by the chosen registrar. </li></ul>
    5. 5. Benefits and Uses: <ul><li>Can facilitate continuous improvement </li></ul><ul><li>Can Identify System Failures </li></ul><ul><li>Provide feedback to Management regarding efficiency of the Quality System </li></ul>
    6. 6. <ul><li>How does this apply to my organization? </li></ul>
    7. 7. <ul><li>Decide the scope of the audit </li></ul><ul><ul><li>Full </li></ul></ul><ul><ul><li>Partial </li></ul></ul><ul><li>How will it be conducted </li></ul><ul><ul><li>Upstream </li></ul></ul><ul><ul><li>Downstream </li></ul></ul><ul><ul><li>Across Processes </li></ul></ul>Steps to a Successful Internal Audit
    8. 8. Scope of the Audit <ul><li>Full audit of the entire Quality System </li></ul><ul><ul><li>How many auditors will be needed </li></ul></ul><ul><ul><li>How will responsibilities be divided </li></ul></ul><ul><ul><li>Appoint a lead auditor to keep the audit focused </li></ul></ul><ul><li>Partial </li></ul><ul><ul><li>Which departments or processes </li></ul></ul><ul><ul><li>Which clause of the standard </li></ul></ul>
    9. 9. How Will the Audit Be Conducted <ul><li>Upstream-starting with the final process and working backwards to the beginning </li></ul><ul><li>Downstream-starting with the first process and flowing forward </li></ul><ul><li>Horizontal-across similar processes </li></ul>
    10. 10. Steps to a Successful Internal Audit cont. <ul><li>Develop a checklist </li></ul><ul><li>Perform the audit </li></ul><ul><li>Record findings </li></ul><ul><li>Follow-up </li></ul>
    11. 11. Develop a Checklist <ul><li>Become familiar with the processess and the associated documentation to be audited </li></ul><ul><li>Make notes on possible questions </li></ul><ul><li>List items to look for and observe </li></ul><ul><li>Note paragraph of the standard being checked next to the item being audited </li></ul><ul><li>Leave space to record observations </li></ul><ul><li>Use only one sheet per process or area </li></ul>
    12. 12. Sample checklist <ul><li>Wavesolder Process 3/3.0 </li></ul><ul><li>Component and Board Handling 3/3.2 </li></ul><ul><ul><li>Are components labeled and stored properly? ________ </li></ul></ul><ul><ul><li>Are operators following proper board handling procedures? ______ </li></ul></ul><ul><li>Safety Procedures 3/3.6 </li></ul><ul><ul><li>Are operators wearing appropriate safety equipment? ________ </li></ul></ul><ul><ul><li>Is the area clean and obstacle free? ____________ </li></ul></ul><ul><li>Interview two operators </li></ul><ul><ul><li>What is the procedure for loading a board into the machine? </li></ul></ul><ul><ul><li>How far apart should the boards be in the machine </li></ul></ul><ul><ul><li>When is it necessary to wear safety glasses? </li></ul></ul>
    13. 13. The Internal Audit <ul><li>Maintain control of the audit </li></ul><ul><li>Be professional </li></ul><ul><li>Remain objective-look at the facts </li></ul><ul><li>Observe everything </li></ul>
    14. 14. Audit Interviews <ul><li>Ask open-ended questions </li></ul><ul><li>Use hypothetical questions </li></ul><ul><li>Encourage free speaking </li></ul><ul><li>Observe body language of the interviewee and adapt question if needed </li></ul><ul><li>Maintain eye contact </li></ul>
    15. 15. Audit Interviews cont. <ul><li>Minimize note taking during interview </li></ul><ul><li>Restate your understanding of their response </li></ul>
    16. 16. Recording Observations <ul><li>Record location of observation </li></ul><ul><li>List the names of interviewees and their position </li></ul><ul><li>Notes on non-conformances should be short and to the point but thorough </li></ul>
    17. 17. Non-conformances <ul><li>Issue Corrective Action Requests (CAR) </li></ul><ul><ul><li>Make sure it is thorough </li></ul></ul><ul><ul><li>Note ownership </li></ul></ul><ul><ul><li>Note the paragraph of the standard that has been violated </li></ul></ul><ul><ul><li>State requirements of resolutions </li></ul></ul>
    18. 18. CAR Response <ul><li>Must have specific details of implementation </li></ul><ul><li>Must have timeline for completion </li></ul>
    19. 19. Report to Management <ul><li>Reports should be thorough and specific </li></ul><ul><li>Must be reviewed by management to be effective </li></ul>
    20. 20. The External Audit <ul><li>Prior to the audit by the registrar </li></ul><ul><ul><li>Let employees know what to expect from the external audit </li></ul></ul><ul><ul><li>Let employees know what is expected of them </li></ul></ul>
    21. 21. Cessna’s Approach <ul><li>Previous Audit System </li></ul><ul><ul><li>Viewed as disruption </li></ul></ul><ul><ul><li>Viewed as a policing process </li></ul></ul><ul><ul><li>Viewed as non-beneficial </li></ul></ul><ul><ul><li>Program was suspended </li></ul></ul>
    22. 22. Cessna’s Approach <ul><li>New Audit System </li></ul><ul><ul><li>Thorough Phased Procedure Developed </li></ul></ul><ul><ul><li>Teams with representatives from each quality department </li></ul></ul><ul><ul><li>Monthly rolling audits </li></ul></ul><ul><ul><li>Fosters continuous improvement of their quality system </li></ul></ul>
    23. 23. Quiz <ul><li>How does auditing facilitate quality improvement? </li></ul><ul><li>What does ISO require in regards to audits? </li></ul>
    24. 24. Summary: <ul><li>Internal audits can be a tool for retaining certification </li></ul><ul><li>Can also be a tool for process improvement </li></ul><ul><li>Improves organizational awareness </li></ul><ul><li>Improves communication </li></ul>