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Are you Ready for ISO9001:2015?

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Optimize Calibration Efforts in 5 Steps

Importance of Calibration

The only way to ensure that measurements deliver


the kind of cost, quality and revenue results that help
improve profitability over their entire lifetime, is to
choose the right procedure and schedule to periodical-
ly maintain, calibrate and adjust your scale. Industrial
environments are tough on scales. Periodic calibration
alerts you to a device that is out of specification, such
as a faulty sensor, cable or mechanical component,
and identifies poor performance due to debris, abuse,
temperature or water ingress. Therefore, the frequency
of calibration and routine (user) testing should coin-
cide with a a risk analysis for each weighing process.

Although industry standards and regulations, such


as ISO9001, BRC, FDA and GMP, do not recommend
how often measuring devices need to be calibrated
and tested, there are several steps you can take to
ensure your scale achieves maximum efficiency and
profitability.

Risk-based analysis in 5 Steps


A major revision of ISO9001 in 2015 has changed
to include risk-based thinking. Here are the 5 steps
you need to know to help assess how frequently
calibration and routine testing should be performed:

Step 1 1 2

Evaluate the impact of wrong/inaccurate weighing Severity


(Impact)
results on your business process. Examples include:
• loss of material and time
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• out of specification
• frequency of production stoppage g
tin
es
• potential product recall r et
mo
• damage to your reputation isk=
err
High

Step 2 3
Determine the impact of wrong measurements Likelihood
on staff, consumers and the environment. (Probability)

Step 3

Estimate the probability of the faulty measurement’s de-


tection through existing testing methods prior to shipment.

Weight
4

Smallest net weight


Safety
Factor

5 Calibration &
520g Adjustment (by service) 520g
500g 500g
500g

Time

Calibration Interval Calibration Interval


Calibration and Adjustment (when necessary) by authorized service technician
Routine testing by the instrument user

Step 4

Determine the smallest net weight that must be weighed on the scale. By using your scale
above this limit will ensure continuously good measurements.

Step 5

Define which safety factor should be applied. The safety factor heavily depends on the envi-
ronment. If the environment contains high amounts of vibration, wind or other disturbances
such as untrained users, the safety factor should be set higher.

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2 METTLER TOLEDO © 11/2016 Mettler-Toledo GmbH
Risk-based selection, calibration and operation
METTLER TOLEDO has developed Good Weighing
Practice™, a standardized scientific methodology for
secure selection, calibration and operation of weighing
equipment based on a thorough risk analysis de-
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scribed in the previously mentioned 5 steps.

The METTLER TOLEDO GWP specialist will support you


in defining the right intervals for calibration and routine
testing of your weighing equipment based on an indi-
vidualized risk-assessment and help you implement
this into your quality management system.

Risk-based calibration and routine intervals are intend-


ed to detect any errors that could lead to potential
quality problems, business disruption, health issues
and loss of material or time. In essence you decide the
appropriate service based on your anticipated risks.

www.mt.com/gwp

Mettler-Toledo GmbH
CH-8606 Greifensee, Switzerland
www.mt.com
For more information
Tel. +41 44 944 22 11
Fax +41 44 944 30 60

Subject to technical changes


© 11/2016 Mettler-Toledo GmbH

MTSI 30388042
Indstial Marcom

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