lecture5 mme3110 sem1 1112-1 qc in metrology [compatibility mode]
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Metrology and Measurement
Systems (MME 3110)
Semester 1, 2011-2012
Lecture 5
Quality assurance in metrology:Calibration, Procedures and Requirements
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ISO quality systems as applied
to en ineerin metrolo
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Introduction
Calibration Standards General approach to quality systems
ISO 9000 Quality Standards* ISO 9000: Quality Management and Quality Assurance
Standards Guidelines* ISO 9001: ualit S stems- ualit Assurance in
Contents
Design, Development, Production, Installation andServicing Functions
* ISO 9002: Quality Systems - Quality Assurance inProduction, Installation and Servicing Functions
* ISO 9003: Quality Systems - Quality Assurance in FinalInspection and Test Functions* ISO 9004: Quality management and quality system
elements
ISO 14000:Standards for environmental management Systems
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Introduction
Accuracy in measurements is mandatory
To achieve this accuracy, calibration of theinstruments used to obtain measurements
frequency.
Measurements related to product quality arean important part of quality control systems.
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Introduction
The ISO 9000 series of standards has been
established that provide procedures forensuring that an effective quality system,which meets customers' needs and is
maintained.
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Introduction
Quality Assurance - Main factor in determiningwhether a company succeeds or fails is thequality in the goods and services that it provides
Competition in the market-place is intense andinternational.
quality control has therefore become of vitalimportance.
Hence need for companies to implement soundand effective quality control and quality assurancesystems for measurements -Calibration
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Measurement must be of high quality i.e.
measurement ensures that process
variables within a manufacturing processare maintained within acceptable limitsand also checks that the final parameters
Calibration
of the product are within specifiedtolerances – how?
* using properly calibrated instruments
and transducers* all measurement errors are identified,
quantified and compensated for.
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Calibration Calibration - comparing the output of
the process instrument being calibrated
against the output of a standardinstrument of known accuracy, when
applied to both instruments.
A few standards do exist to ensureeffective calibration process.
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Standard LaboratoriesStandard LaboratoriesStandard LaboratoriesStandard Laboratories A few examples of organizations for accreditation
of standards laboratories include the following:
In the United Kingdom, appropriate NationalStandards Organization for validating StandardsLaboratories is the National Physical Laboratory.
Bureau of Standards
The UK Organization established a National
Measurement Accreditation Service (NAMAS)which monitors both instrument calibration andmechanical testing laboratories
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Primary Reference StandardsPrimary Reference StandardsPrimary Reference StandardsPrimary Reference Standards
This describes the highest level of accuracy that isachievable in the measurement of any particular
physical quantity All items used in Standards Laboratories as secondary
reference standards have to be calibrated against
pr mary re erence stan ar s at appropr ate nterva s otime.
For e.g., the primary reference standard for dimension
measurement is defined by the wavelength of theorange-red line of Krypton light, and this can berealized in any laboratory equipped with an
interferometer.
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Primary Reference StandardsPrimary Reference StandardsPrimary Reference StandardsPrimary Reference Standards
Primary reference standards, listed in Table below
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TraceabilityTraceabilityTraceabilityTraceability
Calibration has achain-like structure inwhich everyinstrument in the
chain is calibratedagainst a moreaccurate instrumentimmediatel above it
in the chain, asshown in Figure.
The knowledge of thefull chain of theinstruments involvedin the procedure isknown as Traceability
Instrument Calibration chain
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Typical TraceabilityTypical TraceabilityTypical TraceabilityTypical Traceability
Typical calibration chain for micrometers
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WHAT IS ISO? A set of standards for quality management
and quality assurance systems developed bythe International Standard Organization
They provide a framework for quality systemdevelopment in all types of industries including
It is just purely a management system that willhelp us to run our business in a more organized
and systematic manner which will lead to a moreconsistent quality of the service that we deliverto our customers
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ISO 9000 Quality standards
The term ISO 9000 is globally referred to as acomplete set of five documents which are
numbered ISO 9000 to ISO 9004. Collectively they are concerned with setting
out procedures that are designed to achieve
. They impose a requirement on suppliers of
goods and services to establish and maintainan effective, economical and demonstrablesystem, which ensures that what they supplyconforms to specified requirements.
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ISO 9000 Quality standards contd. ISO 9000 -The first document in the set (ISO 9000 to
ISO 9004)-is not really a standard itself but consistsmerely of guidelines for selecting and using ISO 9001 toISO 9003.
The ISO 9001 to ISO 9003 documents are the actualquality assurance standards
,
document, which provides guidelines for developing andimplementing quality systems.
The ISO quality standards have now been adopted by
most countries around the world, but they are oftenpublished in individual countries with slightly differentprefixes or codes so that they harmonize with pre-existing national coding systems for standards.
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ISO 9000: Quality Management and Quality Assurance
Standards Guidelines- Published in four separate parts
Part 1 (ISO 9000-1) gives general guidance aboutquality management and the implementation of quality
assurance procedures. Part 2 (ISO 9000-2) provides more detailed guidelines
on the implementation of ISO 9001-9003.
Part 3 (ISO 9000-3) gives specific guidance about theapplication of ISO 9001 where software either is theproduct or is Part of the product.
Part 4 (ISO 9000-4) gives guidance on developing andmanaging a programme which assures customersabout the reliability and maintainability of products.
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ISO 9001:
ISO 9001 is the standard of most relevance tomanufacturing companies. It lays down
procedures for ensuring quality assurance inall aspects of manufacturing, including
installation and testing, servicing functions
The requirements to be satisfied can be readfrom the full standard (ISO 9001)
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ISO 9002
ISO 9002: Quality Assurance in Production,Installation and Servicing Functions
ISO 9002 is a subset of ISO 9001 intendedf r m ni h nl r vi
manufacturing, installation and test function(i.e. no product design). It also applies tocompanies that only provide a servicefunction- e.g. specialized cleaning services)
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ISO 9003
ISO 9001-9003 lay down procedures to be followedwhen selecting, using, calibrating, controlling andmaintaining measurement standards and measuring
equipment. A supplementary document, ISO 10012-1
(http://www.iso.ch/ ) defines the necessary procedures
in more detail and also gives some guidance aboutimplementation
ISO 9003: Quality Assurance in final Inspection and
Test Functions. It applies to companies that only provide a supply,
inspection and test service (i.e. no product
manufacture)
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ISO 9004
ISO 9004 consisting of four parts, which
together provide further guidance on
developing and implementing qualitysystems
The general requirements of qualitysystem management, documentation,audits, costing, training and the control of
measurement and testing equipment arecovered
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ISO 9004 contd.
Part 1 (ISO 9004-1) gives general guidelines.
Part 2 (ISO 9004-2) gives more specific
guidelines where a supplier is providing aservice.
-
guidelines where a supplier is providingprocessed materials.
Part 4 (ISO 9004-4) gives advice on how toimplement a system designed to achievecontinuous improvements in quality
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ISO 14000 Standards for environmental
management systems The major difference between ISO 9000 and
14000 standards is in their application.
The ISO 9000 is concerned with quality ingoods manufactured and services provided.
ISO 14000 covers environmental concernsof air and water pollution, wasteminimization /disposal and good practice in
product use.
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General approach to quality systems
For a quality control system to operatesuccessfully in a company, certainconditions have to be satisfied.
The procedures instituted must beorientated towards preventing quality
problems occurring, i.e. not being merefault detection-type systems
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General approach to QA
When introducing quality control procedures,it’s very important that employees at all levelsin a company are aware of the reason for them,understand fully how to operate them, and co-
operate enthusiastically in implementing them
Although a quality control manager must beappointed to design and monitor quality control
systems, the control system is not a one-
person show. All personnel in a company mustbe encouraged to share in the duty of
maintaining good quality and take pride in it
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General approach to QAs
Quality control procedures shouldevolve and develop over a period of
time. Regular review is necessary toensure that quality control procedurescontinue to be efficient and remain the
most appropriate as technologicaldevelopments take place
Reviews must also take changes inmarket forces into account and fullymonitor customer satisfaction, need and
expectations
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Process Instrument CalibrationProcess Instrument CalibrationProcess Instrument CalibrationProcess Instrument Calibration Changes in instrument characteristics are
caused by factors like mechanical wear,and the effects of dirt, dust, fumes andchemicals in the o eratin environment.
Periodic recalibration is necessary becausethe characteristics of any measuringinstrument change over a period of time
and affect the relationship between theinput and output
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Process Instrument CalibrationProcess Instrument CalibrationProcess Instrument CalibrationProcess Instrument Calibration
During calibration process, the instrumentis tested over its whole range by repeating
the comparison procedure for a range ofinputs
The instrument used as a standard forcalibration process must be kept solely for
calibration duties and it must never beused for other purposes
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All instrument characteristics are affected tosome extent by environmental conditions,
and any parameters given in data sheetsonly apply for specified conditions
Process Instrument CalibrationProcess Instrument CalibrationProcess Instrument CalibrationProcess Instrument Calibration
- ere ore, as ar as pract ca e, t esesame environmental conditions should be
reproduced during calibration procedures
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For proper management of calibrationprocedures, it is important that the
performance of all calibration operations isassigned as the clear responsibility of just
Process Instrument CalibrationProcess Instrument CalibrationProcess Instrument CalibrationProcess Instrument Calibration
.
Assigned person should have total controlover the calibration function, and be able
to limit access to the calibration laboratoryto designated approved personnel only
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Process Instrument CalibrationProcess Instrument CalibrationProcess Instrument CalibrationProcess Instrument Calibration
One of the clauses in ISO 9000 requiresthat all persons using calibration equipmentbe adequately trained and the training mustbe adequate and targeted at the particular
nee s o e ca ra on sys ems nvo ve
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Process Instrument CalibrationProcess Instrument CalibrationProcess Instrument CalibrationProcess Instrument Calibration
Over the longer term, the characteristics ofthe working standard will drift, mainly owing
to ageing effects in components within it.
quality-related measurements must becalibrated from time to time against astandard instrument (secondary referencestandard) of higher accuracy at appropriateintervals of time
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Proper records should be maintained forcalibration procedures. A separate record
should be kept for every instrument in thefactory, whether it is in use or kept as a spare.This record should start b ivin a descri tion
Process Instrument CalibrationProcess Instrument CalibrationProcess Instrument CalibrationProcess Instrument Calibration
of the instrument and then stating the requiredcalibration frequency
When the working standard instrument hasbeen calibrated by an authorized standards
laboratory, a calibration certificate will be issued
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Documentation in workplace
This deals with the maintenance of
measurement systems and the operationof calibration procedures
It must ive a full descri tion of the
measurement requirements throughout theworkplace, the instruments used, thecalibration systems and procedures
operated
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Documentation
Calibrate all measuring instruments underspecified environmental conditions so that their
measuring accuracy is known over the wholemeasurement range
characteristics under environmental conditionsdifferent from the calibration conditions
Establish measurement procedures whichminimize the effect of environmental conditionchanges on the measuring instruments
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Documentation
Calculate the bounds of measurement error ofan instrument under normal operating
conditions Determine the rate of change of instrument
experimentation Hence to determine the frequency at which
instruments should be re-calibrated and the
maximum possible measurement error whenthe instrument has drifted furthest from itsspecification immediately before calibration
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Documentation
Combine all instrument measurement errorlevels into a figure which expresses the
cumulative error level of the wholemeasurement process (where a measurement
instrument)
Document all measurement and calibrationprocedures
S
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Summary
Quality must be ensured in measurement