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Corrective & Preventive Action Programme

Corrective & Preventive Action Programme. Corrective and preventive action managed by one programme Closely linked to the internal audit programme Managed by the Quality Manager Process managed using corrective action form. 1. CAR Raised. Corrective and Preventive Action Process.

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Corrective & Preventive Action Programme

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  1. Corrective & Preventive Action Programme • Corrective and preventive action managed by one programme • Closely linked to the internal audit programme • Managed by the Quality Manager • Process managed using corrective action form

  2. 1.CAR Raised Corrective and Preventive Action Process 2.CAR logged 3.Investigate root cause of problem and identify CA Problem Solving Team Major change ? ManagementReview 4.Implement CA, Update documentation No Yes 5.CA effective? End

  3. 1. Raising a Corrective or Preventive Action • Audits (internal and external) • Observations by staff • Management review • Client feedback

  4. 2. Recording the CAR • Initiate CAR form • Record corrective or preventive action • categorise • Quality Manager to • log in CAR • allocate unique CAR identification number

  5. 3.1 Investigating the Corrective Action • Investigate root cause of the problem • why did the problem occur ? • Potential causes: • samples • methods and procedures • staff skills and training • equipment and calibration • Record CAR

  6. 3.2 Identify Possible Corrective Action • Identify potential corrective action • what would prevent the problem from happening again ? • Problem solving team • if many staff or departments affected • if major non-conformance • Record on CAR

  7. 4. Implement Corrective Action • Implement the action/s • make changes to the system • Record • Update documentation

  8. 5. Was Corrective Action Effective ? • Verify and record effectiveness • has it prevented the problem from occurring again ? • follow up • additional audits

  9. Equipment Calibration

  10. Outline • Requirements for calibration • Equipment identification • Calibration and maintenance records • Equipment documentation • Subcontractors • Benefits of calibration and maintenance

  11. Equipment Calibration Required: • By ISO 9000 • clause 4.11.1 and 4.11.2 • By ISO/IEC 17025 • clauses 5.5 and 5.6

  12. Requirements of ISO/IEC 17025 • Unique number identifying each piece of equipment • Routinely maintain & calibrate • Document maintenance procedures • make them easily accessible

  13. Requirements of ISO/IEC 17025 • Measurements traceable to national measurement standards • Results must be accurate and clear • File all records appropriately

  14. Equipment Identification • Assign unique identification number to each piece of equipment & reference material • May be equipment serial number • OR number assigned by laboratory • Display identification number on the equipment in a visible area

  15. Equipment Records & Maintenance • Maintain records of: • Equipment name, unique number • Date received, condition upon installation • Maintenance history, future maintenance dates • Service/calibrate equipment & reference materials at regular intervals - per NATA specifications

  16. Documentation • Each piece of equipment must have full documentation of: • Instructions for proper use • Maintenance procedure • Documentation accessible to all staff • More than one copy may be required

  17. Traceability • Calibration of reference material & test equipment must be traceable to national measurement standards

  18. Results • As calibration certificate, test report or test certificate • Accurate and clear • stating any measurement uncertainty • Include information necessary for interpretation of the calibration

  19. Records • Must include: • which equipment was calibrated • who performed calibration • File records in a safe location

  20. Sub-Contractors • Calibrations by sub-contractors must also comply as above • Do not assume sub-contractor: • will follow necessary procedures • is authorised to calibrate a particular piece of equipment

  21. Benefits of a Maintenance System • Ensures that equipment operates within specifications • Maintains uniformity and quality of testing • Identifies potential problems before they become major • Reduces costs

  22. Preventive Maintenance at NRL • Procedures, Work Instructions • Document calibration steps for each piece of equipment • List limitations and acceptability criteria

  23. Preventive Maintenance at NRL • In-house application • developed in Microsoft Access • inventory of critical equipment • calibration histories • help identify patterns of non-conformities • maintenance schedule • ensures no equipment is overlooked

  24. Preventive Maintenance at NRL • Confirmation sticker on each piece of equipment shows status • green sticker- confirmed for use • within dates • red sticker - decommissioned • must not be used • additional information

  25. Preventive Maintenance at NRL • Original calibration records & test results • filed by equipment category & unique identifier • archived at end of year • accessible for audits

  26. Preventive Maintenance at NRL • Contractors informed of requirements • Where possible yearly contracts are established and revised to ensure compliance

  27. Outcomes • Reproducibility in testing • Confidence in equipment • Reduced errors & down-time • Reduced cost of equipment break-downs & replacements

  28. Management Review

  29. Outline • What is required • What happens • Inputs into the review • Outputs

  30. Management Review Required: • By ISO 9000 • clause 4.1.3 • By ISO/IEC 17025 • clause 4.14

  31. Management Review • Review: • Effectiveness of quality system • Continued suitability • Resourcing • Training • Make necessary changes

  32. Management Review • Input (Quality Manager’s report): • External and internal audits • Corrective and preventive actions • Customer complaints • Interlaboratory comparisons

  33. Management Review • Consider impact of any changes in functions or external environment • Records must be kept

  34. Management Review • By Whom? • Senior management • People who can direct change • Quality Manager involved

  35. Management Review • NRL approach: • Review by Director, Senior Scientist, Quality Manager (6 times/year) • Supplemented by weekly team meetings • Different for different organisations

  36. Management Review • General Requirements for Registration 3.02.3 “The effectiveness of the quality system shall be reviewed by management at least once per year.”

  37. Management Review • ISO/IEC 17025 4.14.1 “in accordance with a predetermined schedule” “A typical period for conducting a management review is once every 12 months”

  38. Management Review • Keep changes rational • Integrate with other management processes where appropriate and possible

  39. Management Review • Outcomes: • Minutes with actions, responsibilities • Corrective action as appropriate

  40. Review of the Aims of the QMS Section • To clarify the requirements of a Quality Management System (QMS)

  41. Expected Outcomes of the QMS Section • Know how to meet the requirements of ISO/IEC 17025 or ISO 9001 by implementing a practical, easy to maintain QMS

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