Corrective Preventive Action Programme l Corrective and preventive

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Corrective & Preventive Action Programme l Corrective and preventive action managed by one programme

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

1. CAR Raised 2. CAR logged Problem Solving Team Corrective and Preventive Action Process

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

1. Raising a Corrective or Preventive Action Audits (internal and external) l Observations by

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

2. Recording the CAR Initiate CAR form l Record corrective or preventive action l

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

3. 1 Investigating the Corrective Action l Investigate root cause of the problem Ø

3. 1 Investigating the Corrective Action l Investigate root cause of the problem Ø why l did the problem occur ? Potential causes: Ø samples Ø methods Ø staff and procedures skills and training Ø equipment l and calibration Record CAR

3. 2 Identify Possible Corrective Action l Identify potential corrective action Ø what would

3. 2 Identify Possible Corrective Action l Identify potential corrective action Ø what would prevent the problem from happening again ? l l Problem solving team Ø if many staff or departments affected Ø if major non-conformance Record on CAR

4. Implement Corrective Action l Implement the action/s Ø make changes to the system

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

5. Was Corrective Action Effective ? l Verify and record effectiveness Ø has it

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

Equipment Calibration

Equipment Calibration

Outline l Requirements for calibration l Equipment identification l Calibration and maintenance records l

Outline 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 Ø clause l 4. 11. 1 and

Equipment Calibration Required: l By ISO 9000 Ø clause l 4. 11. 1 and 4. 11. 2 By ISO/IEC 17025 Ø clauses 5. 5 and 5. 6

Requirements of ISO/IEC 17025 l Unique number identifying each piece of equipment l Routinely

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

Requirements of ISO/IEC 17025 l Measurements traceable to national measurement standards l Results must

Requirements of ISO/IEC 17025 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

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

Equipment Records & Maintenance l Maintain records of: Ø Equipment Ø Date name, unique

Equipment Records & Maintenance l Maintain records of: Ø Equipment Ø Date name, unique number received, condition upon installation Ø 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: Ø Instructions for

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

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

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

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

Records l Must include: Ø which Ø who l equipment was calibrated performed calibration

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

Sub-Contractors l Calibrations by sub-contractors must also comply as above l Do not assume

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

Benefits of a Maintenance System l Ensures that equipment operates within specifications l Maintains

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 Ø Reduces costs

Preventive Maintenance at NRL l Procedures, Work Instructions Ø Document calibration steps for each

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

Preventive Maintenance at NRL l In-house application Ø developed Ø inventory of critical equipment

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

Preventive Maintenance at NRL l Confirmation sticker on each piece of equipment shows status

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

Preventive Maintenance at NRL l Original calibration records & test results Ø filed by

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

Preventive Maintenance at NRL l Contractors informed of requirements l Where possible yearly contracts

Preventive Maintenance at NRL 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

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

Management Review

Management Review

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

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

Management Review Required: l By ISO 9000 Ø clause l 4. 1. 3 By

Management Review Required: l By ISO 9000 Ø clause l 4. 1. 3 By ISO/IEC 17025 Ø clause 4. 14

Management Review l Review: Ø Effectiveness Ø Continued of quality system suitability Ø Resourcing

Management Review l Review: Ø Effectiveness Ø Continued of quality system suitability Ø Resourcing Ø Training ð Make necessary changes

Management Review l Input (Quality Manager’s report): Ø External and internal audits Ø Corrective

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

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

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

Management Review l By Whom? Ø Senior management Ø People who can direct change

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

Management Review l NRL approach: Ø Review by Director, Senior Scientist, Quality Manager (6

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

Management Review l General Requirements for Registration 3. 02. 3 “The effectiveness of the

Management Review l General Requirements for Registration 3. 02. 3 “The effectiveness of the quality system shall be reviewed by management at least once per year. ”

Management Review l ISO/IEC 17025 4. 1 “in accordance with a predetermined schedule” “A

Management Review l ISO/IEC 17025 4. 1 “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

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

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

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

Review of the Aims of the QMS Section l To clarify the requirements of

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

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