Sunday, February 26, 2017

Calibration chain and traceability

Calibration and traceability requirements in ISO/QS 9000 are often interpreted as only requiring a calibration sticker on the measuring equipment and the reference to a NIST test number on a calibration certificate. The presentation explores the technical background for requiring calibration and traceability and how the real calibration needs are determined.

The calibration facilities provided within the instrumentation department of a company provide the first link in the calibration chain. Instruments used for calibration at this level are known as working standards. As such working standard instruments are kept by the instrumentation department of a company solely for calibration duties, and for no other purpose, then it can be assumed that they will maintain their accuracy over a reasonable period of time because use-related deterioration in accuracy is largely eliminated. However, over the longer term, the characteristics of even such standard instruments will drift, mainly due to ageing effects in components within them. Therefore, over this longer term, a programme must be instituted for calibrating working standard instruments at appropriate intervals of time against instruments of yet higher accuracy. The instrument used for calibrating working standard instruments is known as a secondary reference standard. This must obviously be a very well-engineered instrument that gives high accuracy and is stabilized against drift in its performance with time. This implies that it will be an expensive instrument to buy. It also requires that the environmental conditions in which it is used be carefully controlled in respect of ambient temperature, humidity etc. When the working standard instrument has been calibrated by an authorized standards laboratory, a calibration certificate will be issued. This will contain at least the following information:

the identification of the equipment calibrated
the calibration results obtained
the measurement uncertainty
any use limitations on the equipment calibrated
the date of calibration
the authority under which the certificate is issued.
The establishment of a company Standards Laboratory to provide a calibration facility of the required quality is economically viable only in the case of very large companies where large numbers of instruments need to be calibrated across several factories. In the case of small to medium size companies, the cost of buying and maintaining such equipment is not justified. Instead, they would normally use the calibration service provided by various companies that specialize in offering a Standards Laboratory. What these specialist calibration companies effectively do is to share out the high cost of providing this highly accurate but infrequently used calibration service over a large number of companies. Such Standards Laboratories are closely monitored by National Standards Organizations. In the United Kingdom, the appropriate National Standards Organization for validating Standards Laboratories is the National Physical Laboratory (in the United States of America, the equivalent body is the National Bureau of Standards). This has established a National Measurement Accreditation Service (NAMAS) that monitors both instrument calibration and mechanical testing laboratories. The formal structure for accrediting instrument calibration Standards Laboratories is known as the British Calibration Service (BCS), and that for accrediting testing facilities is known as the National Testing Laboratory Accreditation Scheme (NATLAS). Although each country has its own structure for the maintenance of standards, each of these different frameworks tends to be equivalent in its effect. To achieve confidence in the goods and services that move across national boundaries, international agreements have established the equivalence of the different accreditation schemes in existence. As a result, NAMAS and the similar schemes operated by France, Germany, Italy, the USA, Australia and New Zealand enjoy mutual recognition. The British Calibration Service lays down strict conditions that a Standards Laboratory has to meet before it is approved. These conditions control laboratory management, environment, equipment and documentation. The person appointed as head of the laboratory must be suitably qualified, and independence of operation of the laboratory must be guaranteed.

 

The management structure must be such that any pressure to rush or skip calibration procedures for production reasons can be resisted. As far as the laboratory environment is concerned, proper temperature and humidity control must be provided, and high standards of cleanliness and housekeeping must be maintained. All equipment used for calibration purposes must be maintained to reference standards, and supported by calibration certificates that establish this traceability. Finally, full documentation must be maintained. This should describe all calibration procedures, maintain an index system for recalibration of equipment, and include a full inventory of apparatus and traceability schedules. Having met these conditions, a Standards Laboratory becomes an accredited laboratory for providing calibration services and issuing calibration certificates. This accreditation is reviewed at approximately 12 monthly intervals to ensure that the laboratory is continuing to satisfy the conditions for approval laid down.

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