IMPORTANCE OF CALIBRATION

There are three main reasons for having instruments calibrated:

1 To ensure readings from an instrument are consistent with other
measurements.
2 To determine the accuracy of the instrument readings.
3 To establish the reliability of the instrument i.e. that it can be trusted.
My company needs to meet the requirements of QA standard ISO9001:2008. Is
calibration required?
Yes: Demonstrable control of measurement and test equipment is required.
Part of this is ensuring that instruments are calibrated on a rational periodic cycle, and
that records are maintained and reviewed.
Does calibration affect me?
Yes: even the most precise measurement instrument is of no use if you cannot be sure
that it is reading accurately or, more realistically, that you know what the error of
measurement is.
How is calibration done?
By checking the instrument against known reference standards that have themselves
been calibrated in a chain of measurements that can be traced back to agreed
International Standards the system of SI units for example the Volt; Ampere; Watt;
meter; liter. (These standards have replaced the National Standards that were for
many years the traceability requirement).
How often should my instrument be calibrated?
This depends on how important the measurements being made are to your product or
service; the degree of wear and tear that the instrument will experience in service;
the stability of the instrument itself and a review of the calibration records that
already exist to determine whether adjustment has been needed previously. OTC
recommends a starting periodicity of 12 months for most instruments with an increase
in calibration frequency (to 6 or 9 months) if adjustment is required, and a reduction in
periodicity to 2 years after a sequence of annual calibrations has shown that
adjustment has not been needed.

When should you calibrate your measuring device?

A measuring device should be calibrated:

According to recommendation of the manufacturer.

After any mechanical or electrical shock.

Periodically (annually, quarterly, monthly)

Hidden costs and risks associated with the un-calibrated measuring device could be
much higher than the cost of calibration. Therefore, it is recommended that the
measuring instruments are calibrated regularly by a reputable company to ensure that
errors associated with the measurements are in the acceptable range.
What should I do in regard to measurements if I want to be certified according to
ISO/IEC 9001?
Measurements are part of quality management systems. According to clause 7.6 of
ISO 9001, you have to determine which measurements are necessary and
which measurement devices are needed to provide evidence of conformity
of a product to determined requirements. Starting from the product you are
manufacturing, you must identify the parameters to be measured and monitored
during production.
You could begin with the inspection of incoming material and parts or components
which should be checked for compliance with specifications.
If, for example, you ordered sheet metal of a certain thickness, you should check it
before commencing production. You must decide whether a vernier caliper or a
micrometer screw is needed to determine the thickness with sufficient accuracy.
In a similar way, compliance with specifications has to be measured during
production. Therefore, processes have to be established to ensure that the necessary
measurements are carried out in a manner consistent with the requirement.
According to ISO 9001: Where necessary to ensure valid results, measuring
equipment shall be calibrated or verified at specified intervals, or prior to
use, against measurement standards traceable to international or national
measurement standards; where no such standards exist, the basis for
calibration or verification shall be recorded.

Sub clauses of clause 7.6 also stipulate adjustments, identification and

protection of the measuring equipment. Records of the results of calibration
or verification must be maintained. In addition, measurement, analysis and
improvement processes shall be planned, implemented and monitored (clause 8). The
main goal is to demonstrate that all measuring processes comply with the
requirements to demonstrate conformity with specifications, are documented and
properly implemented.
What is metrology and why is it important in international trade?
Metrology is a technical term meaning all activities and procedures related
to measurements. The ultimate goal of metrology, also defined as the
science of measurement and its application (International Vocabulary of
Metrology, 2010), is to ensure correct, comparable and reliable measuring
results.
Metrology can be subdivided into the following areas:

Scientific or general metrology. This part of metrology deals with problems

common to all metrological questions irrespective of the quantity itself. For
instance, it touches on the general theoretical and practical problems related to
units of measurement, the problem of errors in measurement, and the problems
of the metrological properties of measuring instruments.

Industrial metrology. This discipline focuses on measurements in production

and quality control.

Typical issues are calibration procedures and calibration intervals, control of

measurement processes, and management of measuring equipment.

Legal metrology. This term relates to mandatory technical requirements. A

legal metrology service checks these requirements in order to guarantee correct
measurements in areas of public interest, such as trade, health, the environment
and safety (International Vocabulary of Terms in Legal Metrology, 2000).

Measurement enters into practically all commercial operations, from trading in bulk
goods (petroleum, natural gas, metal ores) to the retail sale of goods to the public in
the marketplace. In particular, international trade in manufactured goods and
production processes using parts and components manufactured in different regions
of the world require correct measurements based on an international metrology
system. This can be illustrated by the examples below.

International trade and the significance of a globally accepted system of

units

Suppose you want to know the diameter of a pipe. Do you want the dimension in
centimeters or inches? What is requested by your customer? The centimeter and the
inch are units belonging to two different systems of units. Whereas the centimeter is a
sub multiple of the meter, the unit of length of the International System of Units (SI),
the inch, belongs to the so-called Imperial Measurement System. The SI is the
recommended system and is applied worldwide, whereas imperial units are used in a
few countries or for specific applications.

High-precision measurements as basis of telecommunication and

information technology

Time is the quantity most often measured. With todays technology, the correct time
is disseminated via radio, television, the telephone, the Internet and by satellite. One
example of ultra-precise time measurements is the global positioning system, GPS,
where time signals of atomic clocks from at least three satellites are used to calculate
the position of the receiver on the ground with an accuracy of a fraction of a meter.
These extraordinarily accurate results can be achieved only under the condition that
each clock produces time signals of the same accuracy. This technology helps to make
shipment of goods faster and safer, it facilitates and accelerates the exchange and
retrieval of information and constitutes the base of electronic trade and commerce
(Secrets of Electronic Commerce, 2009).

Contributions of metrology to conformity assessment and certification

In global markets, certificates are often required as evidence of the

compliance of products or services with specified standards or regulations.
In many cases, conformity assessments and the checking of compliance with
standards or regulations require measurements and tests.
Measurements and tests must therefore be correct within specified limits, comparable
and reliable to ensure confidence in certificates.
In general, the accuracy of measuring instruments is achieved through
regular calibrations. Calibration involves comparing a measuring instrument
with a more accurate measurement standard. National measurement
standards, which usually provide the most accurate measurements in a
country, are compared with international or other national standards to

ensure the correct dissemination of units worldwide. If an unbroken chain of

documented calibrations exists from the highest standard down to ordinary
measuring instruments, then the measurements achieved are called
traceable.

The costs and risks of not calibrating

Unfortunately, calibration has costs associated with it and in uncertain economic
times, this activity can often become neglected or the interval between calibration
checks on instruments can be extended in order to cut costs or simply through a lack
of resources or manpower.
However, neglecting calibration can lead to unscheduled production or
machine downtime, product and process quality issues or even product
recalls and rework.
Furthermore, if the instrument is critical to a process or is located in a hazardous area,
allowing that sensor to drift over time could potentially result in a risk to employee
safety. Similarly, an end product manufactured by a plant with poorly calibrated
instruments could present a risk to both consumers and customers. In certain
situations, this may even lead to a company losing its license to operate due
to company not meeting its regulatory requirements. This is particularly
true for the food and beverage sector and for pharmaceutical
manufacturers.
Weighing instruments also need to be calibrated regularly.
Determining the correct mass of a product or material is particularly important for
companies that supply steel, paper and pulp, power, aviation companies, harbors and
retail outlets, who invoice customers based on the mass of what they supply (fiscal
metering). These companies need to prove not only that the mass is accurate but also
that the equipment producing the readings was correctly calibrated.
Invoicing in these industries is often based on process measurements.
There is therefore a growing need to have the metrological quality of these weighing
instruments confirmed by calibration.

Product manufacturing also depends on accurate masses and so laboratories and

production departments in the food and beverage, oil and gas, energy, chemical and
pharmaceutical industries, also need to calibrate their weighing instruments.
Which of my equipment should be calibrated and why?
All measuring and test equipment should be calibrated. Calibration is used
to:

Ensure conformity with product specifications and product quality

requirements,

Avoid the risk of scrap and rejects,

Determine the price, and

Meet requirements for certification, according to ISO 9001:2008, clause

7.6
Meet requirements for certification, according to ISO 22000:2005,
clause 8.3

Calibration has to be carried out because the performance of measuring and test
equipment may change with time as a result of the influence of the environment to
which it is exposed, wear and tear, overload or improper use. The accuracy of the
measurement and test equipment should be checked before use and regularly
calibrated or after exposure to influence factors. Recalibration is not necessary for
certain simple types of measuring instruments made of glass such as measuring
cylinders, pipettes, burettes, or certain thermometers, if used within the working
conditions they were designed for.
During calibration, the value of a quantity measured by the equipment is compared
with the value of the same quantity provided by a measurement standard. If you have
instruments of different accuracy classes for the same quantity and the same
measuring range, at least the instrument with the highest accuracy also known as
precision instrument should be calibrated by a calibration laboratory, preferably by
an accredited calibration laboratory.
The calibrated precision instruments can be used for in-house calibrations of
instruments of lower accuracy. Details of the calibration such as a short

description of the calibration method and/or a sketch, the standard used,

the results obtained, the date and the name of the operator should be
documented and stored together with the operation manuals and other
documents relevant for the instruments.
Usually, the result of a calibration (or measurement) should include a
calculation of the uncertainty. This is a requirement for professional calibration
laboratories. Since the calculation requires a profound knowledge of the calibration
process and of statistics, it might be too complicated and not absolutely necessary for
calibrations requiring not too high accuracies (not too low uncertainties). Instead of
using methods according to the Guide of expression of uncertainty in measurement
(2008), other statements may suffice. For instance, if the accuracy of the standard
used is 10 times higher than that of the instrument to be calibrated, a detailed
calculation would not be necessary for in-house purposes. But calibration
certificates must always indicate the uncertainty.
A sticker should be attached to the instrument after successful calibration
showing the date of the calibration and an indication of the person who
carried it out. It is not recommended to mention the date for the next recalibration
because this might lead to the assumption that no calibrations are necessary until this
date. This is true only if the instrument has not been exposed to abnormal conditions
or if it shows unexpected results. In case the calibration status is no longer valid or the
calibration is doubtful, the instrument should be marked as such and not used until a
recalibration has been carried out.

Is metrology essential for me and what should I observe?

1 Measurements are necessary if you have to meet specifications required by
regulations, standards, your customer, or if you sell your product, for example, by
mass (kg) or length (m). Of interest here are measurements other than those for
inventory purposes, e.g. determining whether sufficient raw material is still
available or how many kg have been produced.
2 Of interest here are accuracy requirements like, for example: 100 mm +/- 0.5 mm
or 2 000 g + 1 g.
Examples: If the accuracy requirement is 0.001 g and your weighing instrument has a
scale interval of 0.005 g, the resolution of your weighing instrument is not sufficient.
However, if the scale interval is 0.002 g and the distance between adjacent scale
marks is sufficiently large so that 0.001 g can be determined as the middle between
two scale marks, the above-mentioned requirement is fulfilled, provided that the
measuring instrument is correctly calibrated. But it is risky to rely on this assumption
because influence factors may reduce the accuracy and the interpolation may be
uncertain.

4 The accuracy should be regularly checked either by comparison with another

measuring instrument of higher accuracy, or by measuring an object representing
a known value of a quantity (e.g. a calibrated gauge block representing a certain
value of the quantity length). Measuring and test equipment need regular
calibrations to ensure correct measurements for the whole range. You should be
suspicious if your instrument:
Has not been calibrated;
The time that has passed since the latest calibration is longer than the one
recommended by the manufacturer of the instrument; or
Your instrument has been exposed to overload, mechanical shocks or vibrations,
wrong supply voltage or other unusual conditions.
Any of these conditions may cause wrong measurements and requires calibration.
5 Calibrations should be documented no matter whether they are carried out inhouse, by the manufacturer or by a third party (calibration in a laboratory).
6. Certification may be required by your customers and may raise your
competitiveness. Even if certification is not required by your customers, think about
the positive effect it may have on your competitiveness. However, you will first have
to spend time and money on the certification process.
Source: Export quality management second edition (ITC) & (PTB)