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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
piece of equipmentpiece of equipment
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
specificationsspecifications
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
piece of equipmentpiece of equipment
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
piece of equipmentpiece of equipment
Benefits of a Maintenance System
Benefits of a Maintenance System
Ensures that equipment operates within Ensures that equipment operates within
specificationsspecifications
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
specificationsspecifications
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
piece of equipmentpiece of equipment
List limitations and acceptability criteriaList limitations and acceptability criteria
Procedures, Work InstructionsProcedures, Work Instructions
Document calibration steps for each Document calibration steps for each
piece of equipmentpiece of equipment
List limitations and acceptability criteriaList limitations and acceptability criteria
Preventive Maintenance at NRLPreventive Maintenance at NRL
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
Preventive Maintenance at NRLPreventive Maintenance at NRL
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
Preventive Maintenance at NRLPreventive Maintenance at NRL
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
Preventive Maintenance at NRLPreventive Maintenance at NRL
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
Management ReviewManagement Review
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
Management ReviewManagement Review
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
Management ReviewManagement Review
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
Management ReviewManagement Review
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
Management ReviewManagement Review
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
Management ReviewManagement Review
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.”
Management ReviewManagement Review
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”
Management ReviewManagement Review
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
Management ReviewManagement Review
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
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