Metrology and Measurement Systems (MME 3110) Semester 1, 2011-2012

Lecture 5
Quality assurance in metrology: Calibration, Procedures and Requirements

ISO quality systems as applied to engineering metrology

Contents
Introduction Calibration Standards General approach to quality systems ISO 9000 Quality Standards * ISO 9000: Quality Management and Quality Assurance Standards Guidelines * ISO 9001: Quality Systems-Quality Assurance in Design, Development, Production, Installation and Servicing Functions * ISO 9002: Quality Systems - Quality Assurance in Production, Installation and Servicing Functions * ISO 9003: Quality Systems - Quality Assurance in Final Inspection and Test Functions * ISO 9004: Quality management and quality system elements ISO 14000:Standards for environmental management Systems

Introduction
Accuracy in measurements is mandatory To achieve this accuracy, calibration of the instruments used to obtain measurements must be carried out at a predetermined frequency. Measurements related to product quality are an important part of quality control systems.

Introduction
The ISO 9000 series of standards has been established that provide procedures for ensuring that an effective quality system, which meets customers' needs and is maintained.

Introduction
Quality Assurance - Main factor in determining whether a company succeeds or fails is the quality in the goods and services that it provides Competition in the market-place is intense and international. Assurance to customers of high standards in quality control has therefore become of vital importance. Hence need for companies to implement sound and effective quality control and quality assurance systems for measurements -Calibration

Calibration
Measurement must be of high quality i.e. measurement ensures that process variables within a manufacturing process are maintained within acceptable limits and also checks that the final parameters of the product are within specified tolerances how? * using properly calibrated instruments and transducers * all measurement errors are identified, quantified and compensated for.

Calibration
Calibration - comparing the output of the process instrument being calibrated against the output of a standard instrument of known accuracy, when the same input (measured quantity) is applied to both instruments.

A few standards do exist to ensure effective calibration process.

Standard Laboratories
A few examples of organizations for accreditation of standards laboratories include the following: In the United Kingdom, appropriate National Standards Organization for validating Standards Laboratories is the National Physical Laboratory. Its equivalent body in the USA is the National Bureau of Standards The UK Organization established a National Measurement Accreditation Service (NAMAS) which monitors both instrument calibration and mechanical testing laboratories

Primary Reference Standards

This describes the highest level of accuracy that is achievable in the measurement of any particular physical quantity All items used in Standards Laboratories as secondary reference standards have to be calibrated against primary reference standards at appropriate intervals of time. For e.g., the primary reference standard for dimension measurement is defined by the wavelength of the orange-red line of Krypton light, and this can be realized in any laboratory equipped with an interferometer.

Primary Reference Standards

Primary reference standards, listed in Table below

Traceability
Calibration has a chain-like structure in which every instrument in the chain is calibrated against a more accurate instrument immediately above it in the chain, as shown in Figure. The knowledge of the full chain of the instruments involved in the procedure is known as Traceability

Instrument Calibration chain

Typical Traceability

Typical calibration chain for micrometers

WHAT IS ISO?
A set of standards for quality management and quality assurance systems developed by the International Standard Organization They provide a framework for quality system development in all types of industries including service organizations It is just purely a management system that will help us to run our business in a more organized and systematic manner which will lead to a more consistent quality of the service that we deliver to our customers

ISO 9000 Quality standards

The term ISO 9000 is globally referred to as a complete 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 high standards in quality assurance. They impose a requirement on suppliers of goods and services to establish and maintain an effective, economical and demonstrable system, which ensures that what they supply conforms to specified requirements.

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 consists merely of guidelines for selecting and using ISO 9001 to ISO 9003. The ISO 9001 to ISO 9003 documents are the actual quality assurance standards ISO 9004, like ISO 9000 is not a standard but a document, which provides guidelines for developing and implementing quality systems. The ISO quality standards have now been adopted by most countries around the world, but they are often published in individual countries with slightly different prefixes or codes so that they harmonize with preexisting national coding systems for standards.

ISO 9000: Quality Management and Quality Assurance Standards Guidelines- Published in four separate parts
Part 1 (ISO 9000-1) gives general guidance about quality 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 the application of ISO 9001 where software either is the product or is Part of the product. Part 4 (ISO 9000-4) gives guidance on developing and managing a programme which assures customers about the reliability and maintainability of products.

ISO 9001:
ISO 9001 is the standard of most relevance to manufacturing companies. It lays down procedures for ensuring quality assurance in all aspects of manufacturing, including product design, development, manufacture, installation and testing, servicing functions
The requirements to be satisfied can be read from the full standard (ISO 9001)

ISO 9002
ISO 9002: Quality Assurance in Production, Installation and Servicing Functions

ISO 9002 is a subset of ISO 9001 intended for companies that only provide a manufacturing, installation and test function (i.e. no product design). It also applies to companies that only provide a service function- e.g. specialized cleaning services)

ISO 9003
ISO 9001-9003 lay down procedures to be followed when selecting, using, calibrating, controlling and maintaining 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 about implementation 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)

ISO 9004
ISO 9004 consisting of four parts, which together provide further guidance on developing and implementing quality systems The general requirements of quality system management, documentation, audits, costing, training and the control of measurement and testing equipment are covered

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 a service. Part 3 (ISO 9004-3) gives more specific guidelines where a supplier is providing processed materials. Part 4 (ISO 9004-4) gives advice on how to implement a system designed to achieve continuous improvements in quality

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 in goods manufactured and services provided. ISO 14000 covers environmental concerns of air and water pollution, waste minimization /disposal and good practice in product use.

General approach to quality systems

For a quality control system to operate successfully in a company, certain conditions have to be satisfied.
The procedures instituted must be orientated towards preventing quality problems occurring, i.e. not being mere fault detection-type systems

General approach to QA
When introducing quality control procedures, its very important that employees at all levels in a company are aware of the reason for them, understand fully how to operate them, and cooperate enthusiastically in implementing them Although a quality control manager must be appointed to design and monitor quality control systems, the control system is not a oneperson show. All personnel in a company must be encouraged to share in the duty of maintaining good quality and take pride in it

General approach to QAs

Quality control procedures should evolve and develop over a period of time. Regular review is necessary to ensure that quality control procedures continue to be efficient and remain the most appropriate as technological developments take place Reviews must also take changes in market forces into account and fully monitor customer satisfaction, need and expectations

Process Instrument Calibration

Changes in instrument characteristics are caused by factors like mechanical wear, and the effects of dirt, dust, fumes and chemicals in the operating environment. Periodic recalibration is necessary because the characteristics of any measuring instrument change over a period of time and affect the relationship between the input and output

Process Instrument Calibration

During calibration process, the instrument is tested over its whole range by repeating the comparison procedure for a range of inputs The instrument used as a standard for calibration process must be kept solely for calibration duties and it must never be used for other purposes

Process Instrument Calibration

All instrument characteristics are affected to some extent by environmental conditions, and any parameters given in data sheets only apply for specified conditions - Therefore, as far as practicable, these same environmental conditions should be reproduced during calibration procedures

Process Instrument Calibration

For proper management of calibration procedures, it is important that the performance of all calibration operations is assigned as the clear responsibility of just one person. Assigned person should have total control over the calibration function, and be able to limit access to the calibration laboratory to designated approved personnel only

Process Instrument Calibration

One of the clauses in ISO 9000 requires that all persons using calibration equipment be adequately trained and the training must be adequate and targeted at the particular needs of the calibration systems involved

Process Instrument Calibration

Over the longer term, the characteristics of the working standard will drift, mainly owing to ageing effects in components within it. Process instruments which are used to make quality-related measurements must be calibrated from time to time against a standard instrument (secondary reference standard) of higher accuracy at appropriate intervals of time

Process Instrument Calibration

Proper records should be maintained for calibration procedures. A separate record should be kept for every instrument in the factory, whether it is in use or kept as a spare. This record should start by giving a description of the instrument and then stating the required calibration frequency When the working standard instrument has been calibrated by an authorized standards laboratory, a calibration certificate will be issued

Documentation in workplace
This deals with the maintenance of measurement systems and the operation of calibration procedures It must give a full description of the measurement requirements throughout the workplace, the instruments used, the calibration systems and procedures operated

Documentation
Calibrate all measuring instruments under specified environmental conditions so that their measuring accuracy is known over the whole measurement range Establish the variation in instrument characteristics under environmental conditions different from the calibration conditions Establish measurement procedures which minimize the effect of environmental condition changes on the measuring instruments

Documentation
Calculate the bounds of measurement error of an instrument under normal operating conditions Determine the rate of change of instrument characteristics over a period of time by practical experimentation Hence to determine the frequency at which instruments should be re-calibrated and the maximum possible measurement error when the instrument has drifted furthest from its specification immediately before calibration

Documentation
Combine all instrument measurement error levels into a figure which expresses the cumulative error level of the whole measurement process (where a measurement is composed of the outputs of more than one instrument) Document all measurement and calibration procedures

Summary
Quality must be ensured in measurement

THE END