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Photocopies

Learn about the importance of controlling records and conducting internal audits to ensure compliance with standards. Topics include documenting procedures, conducting audits, identifying and resolving problems, and management responsibilities.

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Photocopies

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Presentation Transcript

  1. Photocopies • Occasionally need uncontrolled copies • induction? • information for client? • Mark copy as uncontrolled • Explain how in documentation

  2. Handwritten Amendments • May be permitted • Explain how in documentation • Must be authorised • All copies must be amended • Minimise

  3. Control of Records • Documented procedures, records of: • testing • equipment calibration • internal audits • management review • corrective, preventive actions

  4. Control of Records • What was done • Who did it • Immediate recording • Preservation • Alterations - no erasure

  5. Internal Audits

  6. Outline • What is an internal audit ? • Types of Audits • How to meet standard requirements • Effective auditing • Preparing for an audit • Conducting an audit

  7. Internal Audits Required: • By ISO 9000 • clause 4.17 • By ISO/IEC 17025 • clause 4.13 (management requirements)

  8. What is an Internal Audit ? • Systematic and independent examination of the quality management system (QMS) • By someone within the organisation • In addition to external audits

  9. The Internal Audit Process • Scheduled Audits • programme managed by Quality Manager • examine documents, results, processes • identify problems • improve • Unscheduled Audits • investigate problem • improve

  10. Why Internal Auditing ? • Is QMS implemented exactly as intended ? • To investigate a problem • why did it occur ? • how can it be resolved ? • how can it be prevented in future ? • Identify opportunities to improve • Does the QMS meet requirements of standards ?

  11. Types of Internal Audits • Horizontal • all departments audited against one element of standard or procedure • Vertical • one department audited against all • element of standard or procedure

  12. Standard Requirements:ISO 9001 and 17025 • Audit program • Documented procedures • Auditors independent of activity • Audit results documented and reported to management • Prompt action after problems identified • Follow up activities

  13. Management’s Responsibility • Define internal auditing policy • Assign responsibility of internal audit program • Quality Manager • Must be advised of internal audit outcomes • discussed at management review

  14. Quality Manager’s Responsibility • Establish & maintain internal audit system • Develop schedule • Coordinate audits • Manage corrective action system • Advise management audit outcomes

  15. Who Audits ? • Trained & qualified auditors • Quality Manager selects and trains internal auditors • observer on Quality Manager’s audits • fist audit under supervision of qualified auditor • Independent of the activity to be audited

  16. Audit Schedule • Annual • Address all elements of the quality system • not all departments • Frequency ? • critical areas

  17. Documents used in Internal Auditing • Checklists • Corrective action request forms • Audit report forms

  18. Documenting the Audit Program (1) • Quality Manual • quality policy on internal auditing • responsibility for internal audits

  19. Documenting the Audit Program (2) • Internal audit procedure(s) • selection and training of auditors • scheduling audits • responsibilities of auditors • preparation, conducting and reporting on audits • identifying, resolving and following up corrective actions • reporting audit results to management

  20. Effective Auditing (1) • Gather evidence about compliance with quality system or standard

  21. Effective Auditing (2) • Gather information about: • process, operating procedures • staff, equipment, test methods • environment, handling of samples • quality control, verification activities • recording and reporting practices. • Compare with documented system • Identify breakdown in system or departure from procedures

  22. What to Audit • Systems audit • adherence to documented procedures • Technical audit • Technical correctness • adherence to documented procedures/test methods • auditor must have technical knowledge of test • Combination • vertical audit

  23. What to Audit - Technical Audit • Staff • Methods • Equipment • Testing Environment • Samples and Test Items • Quality Control • Computers • Records and Reports

  24. Audit Preparation • Quality Manager determines • audit team • lead auditor • audit details • scope of audit • time, date, duration • Contact auditee • date, time, type & duration

  25. 1. Audit Plan 2. Develop Checklists 3. Opening Meeting Conducting the Audit 4. Gather Evidence 5. Record Results 6. Closing Meeting 7. Audit Report

  26. 1. Audit Plan • Objectives & scope • Collect documents • standard, procedure, work instructions, forms • desk top review • History

  27. 2. Developing Checklists • Guidelines • Review documents • identify important aspects of the activity • list in logical order • set of questions

  28. P-AD-0012 3.5 Audit Follow-up Activities • It may be necessary for a follow-up audit to be performed to verify the effectiveness of any corrective action carried out. Corrective action, and subsequent follow-up audits, should be completed within a time period agreed to by the auditee, in consultation with the auditor. • The Quality Manager should schedule the follow-up audit and enter details on the Audit Schedule and the Audit Status Log.

  29. 3. Opening Meeting • Who ? • auditor/audit team • auditee • any staff from area to be audited that may be interviewed • What ? • Scope • expected duration

  30. 4.1 Gather Evidence about Compliance • Interviews • ask questions about system and its implementation • who, what, when, how, where, why ? • other questions • direct • hypothetical • clarifying

  31. 4.2 Gather Evidence about Compliance • Examine documents • procedures, work instructions, forms, quality manual • copies controlled ? • available ? • correct issue status ? • used in manner intended ? • Quality Records • stored correctly ? • used as objective evidence • many forms

  32. 4.3 Gather Evidence about Compliance • Observe activities • what is said or written may not reflect practice • “show me” • Examine facilities • as travel through laboratory/offices • examine: • equipment • standard of housekeeping • size and layout of working area • environment eg. temperature in lab

  33. 5. Recording Results • Record on checklists • activities which do not adhere to quality system • may be classified • major non-conformance • minor non-conformance • areas for improvement

  34. 6. Closing Meeting(s) • Audit team meeting • discuss audit results • Closing meeting • discuss corrective actions • determine resolution dates • Identify corrective actions • use corrective action forms

  35. 7. Audit Report • Audit details • Summary of findings • corrective actions • numbered • objective evidence • reference the document • observations • Distribute

  36. Corrective and Preventive Action

  37. Outline • What is a corrective action ? • What is a preventive action ? • Corrective and preventive action program • Corrective and preventive action process

  38. Corrective & Preventive Action Required: • By ISO 9000 • clause 4.14 • By ISO/IEC 17025 • clause 4.10 corrective action • clause 4.11 preventive action

  39. Corrective Action • An action taken to correct a problem • incorrect result • departure from procedure

  40. Preventive Action • A proactive process to identify • improvement opportunities • potential sources of non-conformance

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