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Comprehensive Corrective & Preventive Action Program

Streamline corrective and preventive action process with integrated management, root cause analysis, effective implementation, and evaluation. Ensure equipment calibration meets ISO standards for traceability and accuracy.

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Comprehensive Corrective & Preventive Action Program

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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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