corrective & preventive action programme l corrective and preventive action managed by one...

Corrective & Preventive Action Programme

Corrective & Preventive Action Programme

Corrective and preventive action managed by Corrective and preventive action managed by

one programmeone programme

Closely linked to the internal audit programmeClosely linked to the internal audit programme Managed by the Quality ManagerManaged by the Quality Manager Process managed using corrective action Process managed using corrective action

formform

Corrective and preventive action managed by Corrective and preventive action managed by

one programmeone programme

Closely linked to the internal audit programmeClosely linked to the internal audit programme Managed by the Quality ManagerManaged by the Quality Manager Process managed using corrective action Process managed using corrective action

formform

1.1.CAR CAR RaisedRaised1.1.CAR CAR RaisedRaised

2.2.CAR CAR loggedlogged2.2.CAR CAR loggedlogged

3.3.Investigate root Investigate root cause of problem cause of problem and identify CAand identify CA

3.3.Investigate root Investigate root cause of problem cause of problem and identify CAand identify CA

ManagementRManagementRevieweview

ManagementRManagementRevieweview

Major Major change ?change ?

Major Major change ?change ?

5.5.CA CA effective?effective?

5.5.CA CA effective?effective?

4.4.Implement Implement CA, Update CA, Update

documentationdocumentation

4.4.Implement Implement CA, Update CA, Update

documentationdocumentation

EndEndEndEnd

Problem Problem Solving TeamSolving Team

Problem Problem Solving TeamSolving Team

Corrective and Corrective and Preventive Preventive

Action ProcessAction Process

Corrective and Corrective and Preventive Preventive

Action ProcessAction Process

NoNoNoNo YesYesYesYes

1. Raising a Corrective or Preventive Action

1. Raising a Corrective or Preventive Action

Audits (internal and external)Audits (internal and external) Observations by staffObservations by staff Management reviewManagement review Client feedbackClient feedback

Audits (internal and external)Audits (internal and external) Observations by staffObservations by staff Management reviewManagement review Client feedbackClient feedback

2. Recording the CAR2. Recording the CAR

Initiate CAR form Initiate CAR form Record corrective or preventive actionRecord corrective or preventive action

categorisecategorise Quality Manager toQuality Manager to

log in CARlog in CARallocate unique CAR identification numberallocate unique CAR identification number

Initiate CAR form Initiate CAR form Record corrective or preventive actionRecord corrective or preventive action

categorisecategorise Quality Manager toQuality Manager to

log in CARlog in CARallocate unique CAR identification numberallocate unique CAR identification number

3.1 Investigating the Corrective Action

3.1 Investigating the Corrective Action

Investigate root cause of the problemInvestigate root cause of the problemwhy did the problem occur ?why did the problem occur ?

Potential causes:Potential causes:samplessamples

methods and proceduresmethods and procedures

staff skills and trainingstaff skills and training

equipment and calibrationequipment and calibration Record CARRecord CAR

Investigate root cause of the problemInvestigate root cause of the problemwhy did the problem occur ?why did the problem occur ?

Potential causes:Potential causes:samplessamples

methods and proceduresmethods and procedures

staff skills and trainingstaff skills and training

equipment and calibrationequipment and calibration Record CARRecord CAR

3.2 Identify Possible Corrective Action

3.2 Identify Possible Corrective Action

Identify potential corrective actionIdentify potential corrective actionwhat would prevent the problem from happening again ?what would prevent the problem from happening again ?

Problem solving teamProblem solving team

if many staff or departments affectedif many staff or departments affected

if major non-conformanceif major non-conformance

Record on CARRecord on CAR

Identify potential corrective actionIdentify potential corrective actionwhat would prevent the problem from happening again ?what would prevent the problem from happening again ?

Problem solving teamProblem solving team

if many staff or departments affectedif many staff or departments affected

if major non-conformanceif major non-conformance

Record on CARRecord on CAR

4. Implement Corrective Action4. Implement Corrective Action

Implement the action/sImplement the action/smake changes to the systemmake changes to the system

RecordRecord

Update documentationUpdate documentation

Implement the action/sImplement the action/smake changes to the systemmake changes to the system

RecordRecord

Update documentationUpdate documentation

5. Was Corrective Action Effective ?

5. Was Corrective Action Effective ?

Verify and record effectivenessVerify and record effectivenesshas it prevented the problem from occurring has it prevented the problem from occurring

again ?again ?follow up follow up

additional auditsadditional audits

Verify and record effectivenessVerify and record effectivenesshas it prevented the problem from occurring has it prevented the problem from occurring

again ?again ?follow up follow up

additional auditsadditional audits

Equipment CalibrationEquipment CalibrationEquipment CalibrationEquipment Calibration

OutlineOutline

Requirements for calibrationRequirements for calibration

Equipment identificationEquipment identification

Calibration and maintenance recordsCalibration and maintenance records

Equipment documentationEquipment documentation

SubcontractorsSubcontractors

Benefits of calibration and maintenanceBenefits of calibration and maintenance

Requirements for calibrationRequirements for calibration

Equipment identificationEquipment identification

Calibration and maintenance recordsCalibration and maintenance records

Equipment documentationEquipment documentation

SubcontractorsSubcontractors

Benefits of calibration and maintenanceBenefits of calibration and maintenance

Equipment Calibration Required:Equipment Calibration Required:

By ISO 9000By ISO 9000clause 4.11.1 and 4.11.2clause 4.11.1 and 4.11.2

By ISO/IEC 17025By ISO/IEC 17025clauses 5.5 and 5.6clauses 5.5 and 5.6

By ISO 9000By ISO 9000clause 4.11.1 and 4.11.2clause 4.11.1 and 4.11.2

By ISO/IEC 17025By ISO/IEC 17025clauses 5.5 and 5.6clauses 5.5 and 5.6

Requirements of ISO/IEC 17025Requirements of ISO/IEC 17025

Unique number identifying each Unique number identifying each

piece of equipmentpiece of equipment

Routinely maintain & calibrateRoutinely maintain & calibrate

Document maintenance proceduresDocument maintenance proceduresmake them easily accessiblemake them easily accessible

Unique number identifying each Unique number identifying each


Routinely maintain & calibrateRoutinely maintain & calibrate

Document maintenance proceduresDocument maintenance proceduresmake them easily accessiblemake them easily accessible

Requirements of ISO/IEC 17025Requirements of ISO/IEC 17025

Measurements traceable to national Measurements traceable to national

measurement standardsmeasurement standards

Results must be accurate and clearResults must be accurate and clear

File all records appropriatelyFile all records appropriately

Measurements traceable to national Measurements traceable to national

measurement standardsmeasurement standards

Results must be accurate and clearResults must be accurate and clear

File all records appropriatelyFile all records appropriately

Equipment IdentificationEquipment Identification

Assign unique identification number to Assign unique identification number to

each piece of equipment & reference each piece of equipment & reference

materialmaterial

May be equipment serial numberMay be equipment serial numberOR number assigned by laboratoryOR number assigned by laboratory

Display identification number on the Display identification number on the

equipment in a visible areaequipment in a visible area

Assign unique identification number to Assign unique identification number to

each piece of equipment & reference each piece of equipment & reference

materialmaterial

May be equipment serial numberMay be equipment serial numberOR number assigned by laboratoryOR number assigned by laboratory

Display identification number on the Display identification number on the

equipment in a visible areaequipment in a visible area

Equipment Records & Maintenance

Equipment Records & Maintenance

Maintain records of:Maintain records of:Equipment name, unique numberEquipment name, unique number

Date received, condition upon installationDate received, condition upon installation

Maintenance history, future maintenance datesMaintenance history, future maintenance dates

Service/calibrate equipment & reference Service/calibrate equipment & reference

materials at regular intervals - per NATA materials at regular intervals - per NATA

specificationsspecifications

Maintain records of:Maintain records of:Equipment name, unique numberEquipment name, unique number

Date received, condition upon installationDate received, condition upon installation

Maintenance history, future maintenance datesMaintenance history, future maintenance dates

Service/calibrate equipment & reference Service/calibrate equipment & reference

materials at regular intervals - per NATA materials at regular intervals - per NATA


DocumentationDocumentation

Each piece of equipment must have Each piece of equipment must have

full documentation of:full documentation of:Instructions for proper useInstructions for proper use

Maintenance procedureMaintenance procedure

Documentation accessible to all staffDocumentation accessible to all staffMore than one copy may be requiredMore than one copy may be required

Each piece of equipment must have Each piece of equipment must have

full documentation of:full documentation of:Instructions for proper useInstructions for proper use

Maintenance procedureMaintenance procedure

Documentation accessible to all staffDocumentation accessible to all staffMore than one copy may be requiredMore than one copy may be required

TraceabilityTraceability

Calibration of reference material & Calibration of reference material &

test equipment must be traceable to test equipment must be traceable to

national measurement standardsnational measurement standards

Calibration of reference material & Calibration of reference material &

test equipment must be traceable to test equipment must be traceable to

national measurement standardsnational measurement standards

ResultsResults

As calibration certificate, test report or As calibration certificate, test report or

test certificatetest certificate

Accurate and clearAccurate and clearstating any measurement uncertainty stating any measurement uncertainty

Include information necessary for Include information necessary for

interpretation of the calibrationinterpretation of the calibration

As calibration certificate, test report or As calibration certificate, test report or

test certificatetest certificate

Accurate and clearAccurate and clearstating any measurement uncertainty stating any measurement uncertainty

Include information necessary for Include information necessary for

interpretation of the calibrationinterpretation of the calibration

RecordsRecords

Must include:Must include:which equipment was calibratedwhich equipment was calibrated

who performed calibrationwho performed calibration

File records in a safe locationFile records in a safe location

Must include:Must include:which equipment was calibratedwhich equipment was calibrated

who performed calibrationwho performed calibration

File records in a safe locationFile records in a safe location

Sub-ContractorsSub-Contractors

Calibrations by sub-contractors must Calibrations by sub-contractors must

also comply as abovealso comply as above

Do not assume sub-contractor:Do not assume sub-contractor: will follow necessary procedureswill follow necessary procedures

is authorised to calibrate a particular is authorised to calibrate a particular


Calibrations by sub-contractors must Calibrations by sub-contractors must

also comply as abovealso comply as above

Do not assume sub-contractor:Do not assume sub-contractor: will follow necessary procedureswill follow necessary procedures

is authorised to calibrate a particular is authorised to calibrate a particular


Benefits of a Maintenance System

Benefits of a Maintenance System

Ensures that equipment operates within Ensures that equipment operates within


Maintains uniformity and quality of testingMaintains uniformity and quality of testing

Identifies potential problems before they Identifies potential problems before they

become majorbecome major

Reduces costsReduces costs

Ensures that equipment operates within Ensures that equipment operates within


Maintains uniformity and quality of testingMaintains uniformity and quality of testing

Identifies potential problems before they Identifies potential problems before they

become majorbecome major

Reduces costsReduces costs

Preventive Maintenance at NRLPreventive Maintenance at NRL

Procedures, Work InstructionsProcedures, Work Instructions

Document calibration steps for each Document calibration steps for each


List limitations and acceptability criteriaList limitations and acceptability criteria

Procedures, Work InstructionsProcedures, Work Instructions

Document calibration steps for each Document calibration steps for each


List limitations and acceptability criteriaList limitations and acceptability criteria


In-house applicationIn-house applicationdeveloped in Microsoft Access developed in Microsoft Access

inventory of critical equipmentinventory of critical equipment

calibration historiescalibration historieshelp identify patterns of non-conformitieshelp identify patterns of non-conformities

maintenance schedule maintenance schedule ensures no equipment is overlookedensures no equipment is overlooked

In-house applicationIn-house applicationdeveloped in Microsoft Access developed in Microsoft Access

inventory of critical equipmentinventory of critical equipment

calibration historiescalibration historieshelp identify patterns of non-conformitieshelp identify patterns of non-conformities

maintenance schedule maintenance schedule ensures no equipment is overlookedensures no equipment is overlooked


Confirmation sticker on each piece of Confirmation sticker on each piece of

equipment shows statusequipment shows statusgreen sticker- confirmed for usegreen sticker- confirmed for use

within dateswithin dates

red sticker - decommissioned red sticker - decommissioned must not be usedmust not be used

additional informationadditional information

Confirmation sticker on each piece of Confirmation sticker on each piece of

equipment shows statusequipment shows statusgreen sticker- confirmed for usegreen sticker- confirmed for use

within dateswithin dates

red sticker - decommissioned red sticker - decommissioned must not be usedmust not be used

additional informationadditional information


Original calibration records & test Original calibration records & test

resultsresultsfiled by equipment category & unique filed by equipment category & unique

identifieridentifier

archived at end of yeararchived at end of year

accessible for auditsaccessible for audits

Original calibration records & test Original calibration records & test

resultsresultsfiled by equipment category & unique filed by equipment category & unique

identifieridentifier

archived at end of yeararchived at end of year

accessible for auditsaccessible for audits


Contractors informed of requirementsContractors informed of requirements

Where possible yearly contracts are Where possible yearly contracts are

established and revised to ensure established and revised to ensure

compliancecompliance

Contractors informed of requirementsContractors informed of requirements

Where possible yearly contracts are Where possible yearly contracts are

established and revised to ensure established and revised to ensure

compliancecompliance

OutcomesOutcomes

Reproducibility in testingReproducibility in testing

Confidence in equipmentConfidence in equipment

Reduced errors & down-timeReduced errors & down-time

Reduced cost of equipment break-Reduced cost of equipment break-

downs & replacementsdowns & replacements

Reproducibility in testingReproducibility in testing

Confidence in equipmentConfidence in equipment

Reduced errors & down-timeReduced errors & down-time

Reduced cost of equipment break-Reduced cost of equipment break-

downs & replacementsdowns & replacements

Management ReviewManagement Review

OutlineOutline

What is requiredWhat is required

What happensWhat happens

Inputs into the reviewInputs into the review

OutputsOutputs

What is requiredWhat is required

What happensWhat happens

Inputs into the reviewInputs into the review

OutputsOutputs

Management Review Required:Management Review Required:

By ISO 9000By ISO 9000clause 4.1.3clause 4.1.3

By ISO/IEC 17025By ISO/IEC 17025clause 4.14clause 4.14

By ISO 9000By ISO 9000clause 4.1.3clause 4.1.3

By ISO/IEC 17025By ISO/IEC 17025clause 4.14clause 4.14


Review:Review:Effectiveness of quality systemEffectiveness of quality system

Continued suitabilityContinued suitability

ResourcingResourcing

TrainingTrainingMake necessary changesMake necessary changes

Review:Review:Effectiveness of quality systemEffectiveness of quality system

Continued suitabilityContinued suitability

ResourcingResourcing

TrainingTrainingMake necessary changesMake necessary changes


Input (Quality Manager’s report):Input (Quality Manager’s report):External and internal auditsExternal and internal audits

Corrective and preventive actionsCorrective and preventive actions

Customer complaintsCustomer complaints

Interlaboratory comparisonsInterlaboratory comparisons

Input (Quality Manager’s report):Input (Quality Manager’s report):External and internal auditsExternal and internal audits

Corrective and preventive actionsCorrective and preventive actions

Customer complaintsCustomer complaints

Interlaboratory comparisonsInterlaboratory comparisons


Consider impact of any changes in Consider impact of any changes in functions or external environmentfunctions or external environment

Records must be keptRecords must be kept

Consider impact of any changes in Consider impact of any changes in functions or external environmentfunctions or external environment

Records must be keptRecords must be kept


By Whom?By Whom?

Senior managementSenior management

People who can direct changePeople who can direct change

Quality Manager involvedQuality Manager involved

By Whom?By Whom?

Senior managementSenior management

People who can direct changePeople who can direct change

Quality Manager involvedQuality Manager involved


NRL approach:NRL approach:Review by Director, Senior Scientist, Review by Director, Senior Scientist,

Quality Manager (6 times/year)Quality Manager (6 times/year)

Supplemented by weekly team meetingsSupplemented by weekly team meetings

Different for different organisationsDifferent for different organisations

NRL approach:NRL approach:Review by Director, Senior Scientist, Review by Director, Senior Scientist,

Quality Manager (6 times/year)Quality Manager (6 times/year)

Supplemented by weekly team meetingsSupplemented by weekly team meetings

Different for different organisationsDifferent for different organisations


General Requirements for General Requirements for RegistrationRegistration

3.02.33.02.3

““The effectiveness of the quality The effectiveness of the quality system shall be reviewed by system shall be reviewed by management at least once per year.”management at least once per year.”

General Requirements for General Requirements for RegistrationRegistration

3.02.33.02.3

““The effectiveness of the quality The effectiveness of the quality system shall be reviewed by system shall be reviewed by management at least once per year.”management at least once per year.”


ISO/IEC 17025 4.14.1ISO/IEC 17025 4.14.1

““in accordance with a predetermined in accordance with a predetermined schedule”schedule”

““A typical period for conducting a A typical period for conducting a management review is once every 12 management review is once every 12 months”months”

ISO/IEC 17025 4.14.1ISO/IEC 17025 4.14.1

““in accordance with a predetermined in accordance with a predetermined schedule”schedule”

““A typical period for conducting a A typical period for conducting a management review is once every 12 management review is once every 12 months”months”


Keep changes rationalKeep changes rational

Integrate with other management Integrate with other management

processes where appropriate and processes where appropriate and

possiblepossible

Keep changes rationalKeep changes rational

Integrate with other management Integrate with other management

processes where appropriate and processes where appropriate and

possiblepossible


Outcomes:Outcomes:

Minutes with actions, Minutes with actions,

responsibilitiesresponsibilities

Corrective action as appropriateCorrective action as appropriate

Outcomes:Outcomes:

Minutes with actions, Minutes with actions,

responsibilitiesresponsibilities

Corrective action as appropriateCorrective action as appropriate

Review of the Aims of the QMS Section

Review of the Aims of the QMS Section

To clarify the requirements of a Quality To clarify the requirements of a Quality

Management System (QMS) Management System (QMS)

To clarify the requirements of a Quality To clarify the requirements of a Quality

Management System (QMS) Management System (QMS)

Expected Outcomes of the QMS Section

Expected Outcomes of the QMS Section

Know how to meet the requirements of Know how to meet the requirements of

ISO/IEC 17025 or ISO 9001 by ISO/IEC 17025 or ISO 9001 by

implementing a practical, easy to implementing a practical, easy to

maintain QMSmaintain QMS

Know how to meet the requirements of Know how to meet the requirements of

ISO/IEC 17025 or ISO 9001 by ISO/IEC 17025 or ISO 9001 by

implementing a practical, easy to implementing a practical, easy to

maintain QMSmaintain QMS

corrective & preventive action programme l corrective and preventive action managed by one...

Documents