calibration of mmds to meet qms
TRANSCRIPT
ISO 9001:2000 ISO 9001:2000
CalibrationCalibration
Dr. A. AmsavelDr. A. Amsavel
Introduction : CalibrationIntroduction : Calibration
IntroductionIntroduction
Calibration requirementCalibration requirement Purpose / Importance of CalibrationPurpose / Importance of Calibration DefinitionsDefinitions ISO 9001:2000 requirementISO 9001:2000 requirement Calibration of MMDsCalibration of MMDs Documents & RecordsDocuments & Records
Calibration RequirementCalibration Requirement
Requirement by QMS & cGMPRequirement by QMS & cGMP ISO 9001:2000 ISO 9001:2000
7.6 Control of monitoring and measuring devices7.6 Control of monitoring and measuring devices
cGMP: Q7A cGMP: Q7A 5.0 Process Equipment : 5.3 Calibration5.0 Process Equipment : 5.3 Calibration 6.6 Laboratory Control Records6.6 Laboratory Control Records
USFDA: 21 CFR Part 210/211USFDA: 21 CFR Part 210/211
Definition: CalibrationDefinition: Calibration Set of operations that establish, under specified conditions, the Set of operations that establish, under specified conditions, the
relationship between values of quantities indicated by a relationship between values of quantities indicated by a measuring instrument or measuring system, or values measuring instrument or measuring system, or values represented by a material measure or a reference material, and represented by a material measure or a reference material, and the corresponding values realized by standards.the corresponding values realized by standards.
Notes:Notes: 1. 1. The result of a calibration permits either the assignment of value The result of a calibration permits either the assignment of value
measurands to the indications or the determination of corrections with measurands to the indications or the determination of corrections with respect to indications. respect to indications.
2. A calibration may also determine other metrological properties such as 2. A calibration may also determine other metrological properties such as the effect of influence quantities.the effect of influence quantities.
3. The result of a calibration may be recorded in a document, sometimes 3. The result of a calibration may be recorded in a document, sometimes called a calibration certificate or a calibration report.called a calibration certificate or a calibration report.
Calibration! What is it ?Calibration! What is it ?
A set of operations, performed in accordance A set of operations, performed in accordance with a definite procedure, that compares the with a definite procedure, that compares the measurements performed by an instrument to measurements performed by an instrument to those made by a more accurate instrument or a those made by a more accurate instrument or a standard for the purpose of detecting and standard for the purpose of detecting and reporting, or by adjustment, errors met in the reporting, or by adjustment, errors met in the instrument tested. instrument tested.
Purpose of CalibrationPurpose of Calibration
To ensure readings from an instrument are consistent To ensure readings from an instrument are consistent with other instruments and to determine the accuracy with other instruments and to determine the accuracy of the instrument i.e. that it can be trusted for its of the instrument i.e. that it can be trusted for its observed/displayed measured value.observed/displayed measured value.
The value of calibration for industry To ensure that products are manufactured to specifications. To demonstrate that the industry operates a quality system
and technically competent and are able to generate technically valid results.
To increase quality & value of product. The calibrated measuring instruments (working standards)
have the assurance of an unbroken chain of national/international measuring standards.
Definitions (ISO 10012:1997)Definitions (ISO 10012:1997)
Maximum / Limits of permissible error (of a measuring instrument) Extreme values of error permitted by specifications, Extreme values of error permitted by specifications,
regulations, etc. for a given measuring instrument.regulations, etc. for a given measuring instrument.
Measurement process:Set of interrelated resources, activities and influences Set of interrelated resources, activities and influences which produce a measurement.which produce a measurement.
Notes:Notes: ““Influences” are all factors such as those caused by the Influences” are all factors such as those caused by the
environment which may or may not be controlled or environment which may or may not be controlled or controllable and which add to the variability or the bias controllable and which add to the variability or the bias of the process.of the process.
Definitions (cont..)Definitions (cont..) Measuring equipment:Measuring equipment: All of the measuring instruments, measurement All of the measuring instruments, measurement
standards, reference materials, auxiliary standards, reference materials, auxiliary apparatus and instructions that are necessary to apparatus and instructions that are necessary to carry out a measurement.carry out a measurement.
Notes:Notes: 1. This term includes measuring equipment used 1. This term includes measuring equipment used
in the course of testing and inspection, as well as in the course of testing and inspection, as well as that used in calibration.that used in calibration.
2. In the context of this part of ISO 10012, the 2. In the context of this part of ISO 10012, the term “measuring equipment’ is taken to term “measuring equipment’ is taken to encompass “measuring instruments” and encompass “measuring instruments” and “measurement standards”. Moreover, a “measurement standards”. Moreover, a “reference material” is considered to be a type of “reference material” is considered to be a type of “measurement standard”.“measurement standard”.
Uncertainty of measurement:Uncertainty of measurement: Uncertainty- How accurate are the measurements ?Uncertainty- How accurate are the measurements ?
It is a measure of the quality of a measurement & provides the It is a measure of the quality of a measurement & provides the means to assess & minimize the risks and possible means to assess & minimize the risks and possible consequences of poor decision. consequences of poor decision.
Parameter, associated with the result of a measurement Parameter, associated with the result of a measurement that characterizes the dispersion of the values that could that characterizes the dispersion of the values that could reasonably be attributed to the measurand.reasonably be attributed to the measurand.
Notes:Notes:1. 1. The parameter may be, for example, a standard deviation (or a given multiple The parameter may be, for example, a standard deviation (or a given multiple
of it), or the half-width of a interval having a stated level of confidence.of it), or the half-width of a interval having a stated level of confidence.2. 2. It is understood that the result of the measurement is the best estimate of the It is understood that the result of the measurement is the best estimate of the
value of the measurand, and that all components of uncertainty, including value of the measurand, and that all components of uncertainty, including those arising from systematic effects, such as components associated with those arising from systematic effects, such as components associated with corrections and reference standards, contribute to the dispersion.corrections and reference standards, contribute to the dispersion.
Abbreviation
MetrologyMetrology is the is the science of measurement. of measurement. Metrology includes all theoretical and Metrology includes all theoretical and practical aspects of measurement. practical aspects of measurement.
NIST: NIST: National Institute of Standards and Technology (USA), (USA),
BIPM: BIPM: International Bureau of Weights and Measures
NABL: National Accreditation Board for NABL: National Accreditation Board for Testing and Calibration LaboratoriesTesting and Calibration Laboratories
Indicator, Monitoring device and Indicator, Monitoring device and Measuring equipmentMeasuring equipment
What is the difference? What is the difference? For example, a pressure gauge may be used:-For example, a pressure gauge may be used:-
as an indicator (e.g. to ensure that the pressure is as an indicator (e.g. to ensure that the pressure is present); present);
as a monitoring device (e.g. to ensure that the as a monitoring device (e.g. to ensure that the pressure is stable and the process is under control); pressure is stable and the process is under control); and and
as measuring equipment (e.g. where the accurate as measuring equipment (e.g. where the accurate value of the pressure is important for the quality of value of the pressure is important for the quality of product).product).
Calibration and verificationCalibration and verification
Calibration system determines the Calibration system determines the accuracy of measurement and accuracy of measurement and verification system determines the verification system determines the integrity of devices.integrity of devices.
ISO StandardISO Standard ISO 5725: 1994 (P-1,2 &6) Guide on precision of the ISO 5725: 1994 (P-1,2 &6) Guide on precision of the
test methods: Principle and applications (IS:5420 p-test methods: Principle and applications (IS:5420 p-1)1)
ISO 5725: 1994 (P-4) Guide on precision of the test ISO 5725: 1994 (P-4) Guide on precision of the test methods: Inter Laboratory testing (IS:5420 p-2)methods: Inter Laboratory testing (IS:5420 p-2)
ISO 5725: 1994 (P-3 &5) Accuracy & precision ISO 5725: 1994 (P-3 &5) Accuracy & precision ISO 9001: 2000 & ISO 9004 : 2000ISO 9001: 2000 & ISO 9004 : 2000 ISO 10012: 1992 (p-1): Quality Assurance ISO 10012: 1992 (p-1): Quality Assurance
requirement for measuring equipment: requirement for measuring equipment: Meteorological confirmation system for measuring Meteorological confirmation system for measuring equipment.equipment.
ISO 10012: 1997 (p-2): Quality Assurance for ISO 10012: 1997 (p-2): Quality Assurance for measuring equipment: Guidelines for control of measuring equipment: Guidelines for control of measurement processesmeasurement processes
ISO guide 30 & 33ISO guide 30 & 33
Quality management systemQuality management system
ISO ClausesISO Clauses
1.1. ScopeScope2.2. Normative referenceNormative reference3.3. Terms and definitionsTerms and definitions4.4. Quality Management System (4.1-4.2)Quality Management System (4.1-4.2)5.5. Management Responsibility (5.1-5.6)Management Responsibility (5.1-5.6)6.6. Resource Management (6.1-6.4)Resource Management (6.1-6.4)7.7. Product Realization (7.1-7.6)Product Realization (7.1-7.6)8.8. Measurement, analysis and improvement (8.1-8.5) Measurement, analysis and improvement (8.1-8.5)
TrainingServices
22
Do What the Customer Wants
Managed
MeasureAnalyseImprove
GOOD COMPANY
Policy
Customer Focus
Committed
ObjectivesDetermine & CommunicateAuthority & ResponsibilitiesReview
People
Buildings, Equipment,Machinery, etcEnvironment
Planning
Provide Resources
CustomerSatisfaction
System
Processes
Product
Non-conformingProduct
Data & Info
CorrectiveAction
PreventiveAction
Control Our ProcessesControl Our Documentation
ISO
4.14.2
5.1
5.2
5.3 5.4
5.5
5.65.
6.2
6.3
6.4
6.
7.27.37.4
7.
7.1
7.57.6
8.2.1
8.2.28.
8.3
8.2.3
8.2.4
8.4
8.5.2
8.5.3
Selling
PurchasingDesigning
CalibratingDoing It
ISO 9001: 2000 refers where?ISO 9001: 2000 refers where?
6.0 Resource Management6.0 Resource Management6.3 Infrastructure6.3 Infrastructure
Determine, provide and maintain Determine, provide and maintain infrastructure needed infrastructure needed
7.5.1 Control of production and service 7.5.1 Control of production and service provisionprovision
7.6 Control of monitoring and measuring 7.6 Control of monitoring and measuring
devices (MMD)devices (MMD)
7.6 Control of monitoring and measuring 7.6 Control of monitoring and measuring devices (MMD)devices (MMD)
Determine Monitoring and measurements to be made Determine Monitoring and measurements to be made and measurement and monitoring devices needed to and measurement and monitoring devices needed to provide evidence of conformity of product.provide evidence of conformity of product. Calibrate of verify measuring and monitoring devices Calibrate of verify measuring and monitoring devices
(MMD) at specified intervals or prior to use against (MMD) at specified intervals or prior to use against international or national standards. Where no such standard international or national standards. Where no such standard exist record to the basis.exist record to the basis.
Adjust or Re-Adjust necessary.Adjust or Re-Adjust necessary. safeguarded from adjustments that would invalidate the safeguarded from adjustments that would invalidate the
measurement result measurement result protected from damage and deterioration during handling, protected from damage and deterioration during handling,
maintenance and storage. maintenance and storage.
7.6 Control of monitoring and measuring 7.6 Control of monitoring and measuring devices (MMD)devices (MMD)
When the equipment (MMD) is found not to conform to requirements, the organization shall assess and record the validity of the previous measuring results.
The organization shall take appropriate action on the equipment and any product affected.
Records of the results of calibration and verification shall be maintained.
When computer software used in the monitoring and measurement, the ability of to satisfy the intended application shall be confirmed.
How can we do to meet the requirement?How can we do to meet the requirement?
Selection of Instrument Selection of Instrument Least count / Resolution requiredLeast count / Resolution required CalibrationCalibration Frequency of calibrationFrequency of calibration
Indicator, monitoring and measuring Indicator, monitoring and measuring devicesdevices
For example, in some industries, a pressure For example, in some industries, a pressure gauge may be used:-gauge may be used:-
as an indicator (e.g. to ensure that the as an indicator (e.g. to ensure that the pressure is present); pressure is present);
as a monitoring device (e.g. to ensure that as a monitoring device (e.g. to ensure that the pressure is stable and the process is the pressure is stable and the process is under control); and under control); and
as measuring equipment (e.g. where the as measuring equipment (e.g. where the accurate value of the pressure is accurate value of the pressure is important for the quality of product).important for the quality of product).
Least count /Resolution requirementLeast count /Resolution requirement
Least count /Resolution requirement is as required Least count /Resolution requirement is as required for processfor process
Eg-1. Temperature measurement 51 -55°C Eg-1. Temperature measurement 51 -55°C Assume Least count is 1°C Assume Least count is 1°C Measurement accuracy is Measurement accuracy is ± ± 1°C 1°C Measurement : 51,52,53,54,55 Measurement : 51,52,53,54,55 ie 2 out of 5 value likely to out of range 2/5=40%ie 2 out of 5 value likely to out of range 2/5=40%
Eg-2. Temperature measurement 51 -70°C Eg-2. Temperature measurement 51 -70°C Assume Least count is 1°C Assume Least count is 1°C Measurement accuracy is Measurement accuracy is ± ± 1°C 1°C Measurement : 51,52,53.. 69,70 Measurement : 51,52,53.. 69,70 ie 2 out of 20 value likely to out of range 2/20=10%ie 2 out of 20 value likely to out of range 2/20=10%
Least count /Resolution requirementLeast count /Resolution requirement
Ideal tolerance limit is 1/10 = 10%Ideal tolerance limit is 1/10 = 10% For case-1For case-1
51-55 or 53 51-55 or 53 ± 2± 2°C °C 1/101/10thth of 2 is of 2 is ± 0.2± 0.2°C or at least 1/5°C or at least 1/5thth ± ±
0.40.4°C°C For case-1For case-1
51-70 or 60.5 51-70 or 60.5 ± 9.5± 9.5°C °C 1/101/10thth of 10 is of 10 is ± 0.95± 0.95°C or °C or at least 1/5at least 1/5thth ± 1.95± 1.95°C°C
Acceptance criteria / permissible limitAcceptance criteria / permissible limit
Instrument accuracy can be / Instrument accuracy can be / acceptance criteria = measurement acceptance criteria = measurement accuracy or finer but not higher.accuracy or finer but not higher.
CONTROL OF MMDs CONTROL OF MMDs
What we do, What we do, Identify the instruments, Equipments used Identify the instruments, Equipments used
for process, analysis and etc,for process, analysis and etc, List with equipment codeList with equipment code Record the resolution, limit of permissible Record the resolution, limit of permissible
error etcerror etc Calibration frequency & ScheduleCalibration frequency & Schedule Calibration – External / InternalCalibration – External / Internal Record the calibration activity.Record the calibration activity.
CONTROL OF MMDs at MDPLCONTROL OF MMDs at MDPL
SOPs for calibrationSOPs for calibration List the Standards used for List the Standards used for
calibrationcalibration Statuary requirement if any Statuary requirement if any Traceability to standard / master Traceability to standard / master
usedused Maintain relevant recordMaintain relevant record SOP for OOCSOP for OOC
CONTROL OF MMDs at MDPLCONTROL OF MMDs at MDPL
Calibration to cover the entire range Calibration to cover the entire range of MMDof MMD
At least 5 to 6 points to establish At least 5 to 6 points to establish linearitylinearity
Additional points at operational Additional points at operational rangerange
Record the calibrated spare installed Record the calibrated spare installed during calibration of MMD if anyduring calibration of MMD if any
Record for calibration
Format for raw data / certificateFormat for raw data / certificate Refer Standard usedRefer Standard used Review / Compare result with permissible Review / Compare result with permissible
error error Value before and after calibration Value before and after calibration Readjusted if anyReadjusted if any Remark: Correction required / error is to be Remark: Correction required / error is to be
added with the value / readingadded with the value / reading Enter the Status :Passes / failsEnter the Status :Passes / fails Inform the user to add correctionInform the user to add correction Status Label. Status Label.
Evaluation of External Agency
Service provider to be evaluated / auditedService provider to be evaluated / audited NABL accreditationNABL accreditation System / standard followedSystem / standard followed SOP and standardsSOP and standards Masters Masters NISTNIST Qualification & Competence of personQualification & Competence of person Maintain audit report , approved service Maintain audit report , approved service
provider list, contract etcprovider list, contract etc
Verification of External certificate
Have a check list for verificationHave a check list for verification Is agency SOP reviewed & acceptedIs agency SOP reviewed & accepted Is followed as per SOP & referred Is followed as per SOP & referred Is it in the specified formatIs it in the specified format Covered the range of MMD Covered the range of MMD Check for all info like Code no, range Check for all info like Code no, range
resolution, correction, status …..resolution, correction, status ….. Review evidence – stamp and sign & date.Review evidence – stamp and sign & date.
Q7A: 5.3 Calibration
Control, weighing, measuring, monitoring, and testing Control, weighing, measuring, monitoring, and testing equipment critical for ensuring the quality should be calibrated equipment critical for ensuring the quality should be calibrated according to written procedures and an established schedule.according to written procedures and an established schedule.
Equipment calibrations should be performed using standards Equipment calibrations should be performed using standards traceable to certified standards, if they exist.traceable to certified standards, if they exist.
Records of these calibrations should be maintained.Records of these calibrations should be maintained. The current calibration status of critical equipment should be The current calibration status of critical equipment should be
known and verifiable.known and verifiable. Instruments that do not meet calibration criteria should not be Instruments that do not meet calibration criteria should not be
used.used. Deviations from approved standards of calibration on critical Deviations from approved standards of calibration on critical
instruments should be investigated to determine if these could instruments should be investigated to determine if these could have had an effect on the quality of product manufactured have had an effect on the quality of product manufactured using this equipment since the last successful calibration.using this equipment since the last successful calibration.
Q7A: 6.6 Laboratory Control RecordsQ7A: 6.6 Laboratory Control Records
Periodic calibration of laboratory Periodic calibration of laboratory instruments, apparatus, gauges, and instruments, apparatus, gauges, and recording devicesrecording devices
4.2 Documentation4.2 Documentation (ISO 10012-2: 1997)(ISO 10012-2: 1997)
Document should be specific. It should state responsibility and Document should be specific. It should state responsibility and action to be taken. Document the Performance of the action to be taken. Document the Performance of the Measurement processes.Measurement processes.
Guidance:Guidance: Specification of measuring instrumentSpecification of measuring instrument Measurement procedureMeasurement procedure Instruction for the operatorInstruction for the operator Validation reportValidation report Verification reportVerification report Measurement uncertaintyMeasurement uncertainty Limits of permissible errorLimits of permissible error Details of and/ or listing of computer program usedDetails of and/ or listing of computer program used
4.3 Measurement processes4.3 Measurement processes(ISO 10012-2: 1997)(ISO 10012-2: 1997)
The performance characteristic required for the The performance characteristic required for the intended use should be characterizedintended use should be characterized
Eg.Eg. Uncertainty in useUncertainty in use StabilityStability RangeRange ResolutionResolution RepeatabilityRepeatability ReproducibilityReproducibility Skill level of the operator.Skill level of the operator.
Should specify master used, condition of use, Should specify master used, condition of use, other factor affecting the reliability of other factor affecting the reliability of measurement.measurement.
4.10 Indicated failure of a controlled 4.10 Indicated failure of a controlled measurement processes.measurement processes.
When Indicates failure to meet the When Indicates failure to meet the specification, take necessary corrective action specification, take necessary corrective action and document.and document. Decreasing the interval between the checkDecreasing the interval between the check Repairing or eli9minating unstable or unreliable instrumentRepairing or eli9minating unstable or unreliable instrument Extending the time span over which the measurement madeExtending the time span over which the measurement made Decreasing the uncertainty acceptable or increasing the Decreasing the uncertainty acceptable or increasing the
accuracy required for instrumentaccuracy required for instrument Increasi8ng the number of influence quantities being Increasi8ng the number of influence quantities being
checkedchecked Upgrading the operator competenceUpgrading the operator competence
4.13. Records of control of 4.13. Records of control of measurement processes.measurement processes.
Sufficient records should be maintained to Sufficient records should be maintained to demonstrate compliance demonstrate compliance Full description: Identification of Equpt., code, Standard Full description: Identification of Equpt., code, Standard
used, operating condition, operator used, operating condition, operator Relevant data / values including Relevant data / values including measurement measurement
uncertaintyuncertainty Action taken Readjusted if anyAction taken Readjusted if any Date of activity, verification programDate of activity, verification program Identification of verification and documentIdentification of verification and document Person performed the activityPerson performed the activity Qualification of person.Qualification of person.