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

1.CAR Raised 2.CAR logged 3.Investigate root cause of problem and identify CA Management Review Major change ? 5.CA effective? 4.Implement CA, Update documentation EndEnd Problem Solving Team Corrective and Preventive Action Process Corrective and Preventive Action Process NoNoYesYes

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

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

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

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

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

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

Equipment Calibration

Outline l Requirements for calibration l Equipment identification l Calibration and maintenance records l Equipment documentation l Subcontractors l Benefits of calibration and maintenance l Requirements for calibration l Equipment identification l Calibration and maintenance records l Equipment documentation l Subcontractors l Benefits of calibration and maintenance

Equipment Calibration Required: l By ISO 9000  clause and l By ISO/IEC  clauses 5.5 and 5.6 l By ISO 9000  clause and l By ISO/IEC  clauses 5.5 and 5.6

Requirements of ISO/IEC l Unique number identifying each piece of equipment l Routinely maintain & calibrate l Document maintenance procedures  make them easily accessible l Unique number identifying each piece of equipment l Routinely maintain & calibrate l Document maintenance procedures  make them easily accessible

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

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

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

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

Traceability l Calibration of reference material & test equipment must be traceable to national measurement standards

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

Records l Must include:  which equipment was calibrated  who performed calibration l File records in a safe location l Must include:  which equipment was calibrated  who performed calibration l File records in a safe location

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

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

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

Preventive Maintenance at NRL l 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 l 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

Preventive Maintenance at NRL l 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 l 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

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

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

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

Management Review

Outline l What is required l What happens l Inputs into the review l Outputs l What is required l What happens l Inputs into the review l Outputs

Management Review Required: l By ISO 9000  clause l By ISO/IEC  clause 4.14 l By ISO 9000  clause l By ISO/IEC  clause 4.14

Management Review l Review:  Effectiveness of quality system  Continued suitability  Resourcing  Training  Make necessary changes l Review:  Effectiveness of quality system  Continued suitability  Resourcing  Training  Make necessary changes

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

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

Management Review l By Whom?  Senior management  People who can direct change  Quality Manager involved l By Whom?  Senior management  People who can direct change  Quality Manager involved

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

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

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

Management Review l Keep changes rational l Integrate with other management processes where appropriate and possible l Keep changes rational l Integrate with other management processes where appropriate and possible

Management Review l Outcomes:  Minutes with actions, responsibilities  Corrective action as appropriate l Outcomes:  Minutes with actions, responsibilities  Corrective action as appropriate

Review of the Aims of the QMS Section l To clarify the requirements of a Quality Management System (QMS)

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