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Chapter 32: Control of Monitoring and Measuring Equipment

I. Determining monitoring and measurements to be undertaken


What does this mean?
Monitoring periodic or continual observation of operations
Measurement process of associating numbers with physical quantities and phenomena
Monitoring and measurement may be made by unaided human senses, by the use of instruments, or
entirely beyond the capabilities of human senses
Determined requirements are those of the customer, the regulators and the organization
(It is therefore not only a question of measuring the characteristics of the product but also relating these
characteristics to the defined requirements)
Tangible product requirements may be expressed in performance terms (performance requirements) or
in terms of form, fit and function (conformity requirements)
(Performance requirements may not be directly measurable)
(For instance safety requirements have to be translated into physical characteristics that are deemed to
satisfy the requirement. You do not measure safety but the absence of hazard and therefore with a
suspension bridge you would measure loading capacity and with food you would measure the absence of
bugs.)
(You can only search for what is known.)
Intangible product process of measurement varies widely
(Knowledge is measured as the output of a course of study, skill or competence is measured as an output
of training. Perceptions and behaviours are measured where they are vital to service quality.)

Why is this Necessary?


To have a means of relating the requirements to the characteristics to be measured in order to verify
achievement (if unidentified, no knowledge of whether or not requirements had been met before you
delivered the product or service)

How is this Demonstrated?


The monitoring and measurements to be made should be derived from the characteristics defined in the
product requirement (these may be directly measurable, but often the characteristics need to be
translated into measurable parameters)

a. Tangible products - level of measurement may be at system, sub-system, equipment,


component or material level
b. Intangible products - measurement may be at the relationship (long-term interaction
between customer and supplier), encounter (short-term interaction involving a single
purchase) or transaction level (specific activity between representatives of the customer
and supplier)
The method of measurement should be defined in verification procedures (measurement uncertainty),
the devices used to perform the measurements, the competency of the personnel and the physical
environment in which measurements are taken. There may be a tolerance on variable parameters so as
to determine the accuracy required.
.
II. Determining monitoring and measuring equipment needed
What does this mean?
The integrity of products depends on the quality of the equipment used to create and measure their
characteristics
Measuring instrument software or a method or sensor that captures information
(accuracy of devices you use must be controlled, otherwise the parameters stated in the resultant product
specification may not be achievable when the product reaches production)
The measuring and monitoring equipment should encompass the sensor, the transmitter and the receiver
because the purpose of measurement is to take decisions and without receipt of the information no
decisions can be taken. Also, you need to be aware that the transmitter and receiver may degrade the
accuracy and precision of the measurement.
Why is this Necessary?
It is necessary to identify the measuring and monitoring equipment so that a device capable of the
appropriate accuracy and precision is used to take the measurements or monitor the parameters. If the
equipment is defective, the product will not possess the required characteristics and furthermore you will
not know it.
(The equipment you use therefore needs to be controlled)
How is this Demonstrated?
When identifying measuring and monitoring equipment you need to identify the characteristic, the unit
of measure, the target value and then choose appropriate measuring or monitoring equipment. It is
relatively easy to identify the measuring and monitoring equipment for hardware product and processed
material but less easy for services, software and information.
a. Physical Measurement
There are two categories of equipment that determine the selection of physical equipment general
purpose and special to type equipment. You will need to tell inspector or tester which equipment to use
if the measurement requires unusual equipment or the prevailing environmental conditions require that
only equipment be selected that will operate in such an environment. These equipments must then be
specified in the verification procedures.

(In order to demonstrate that you selected the appropriate equipment at some later date, you should
consider recording the actual equipment used in the record of results.)

(A way of reducing the effect is to select equipments that are several orders of magnitude more accurate
than is needed.)
b. Service Measurement
Many service organizations develop metrics for monitoring service quality relative to the type of service
they provide (see table below for Service Quality Measures).
Service provided Measures
Laboratory Turn round time
Conformity with requirements
Calibration accuracy
Time to respond to complaints
Telephone Line availability
Call out response time
Time to reply to complaints
Distribution Time to respond to complaints
Supply delivery time
Received condition
Water Time to reply to complaints
Supply connection time
Water quality
Data analysis Report accuracy
Conformity with requirements
Time to respond to complaints
Education Class size
Percentage of pupils achieving pass
grades

III. Defining the monitoring and measuring processes


What does this mean?
A measurement process consists of:
- operations (i.e., the measurement tasks and the environment in which they are carried out),
- procedures (i.e., how the tasks are performed), devices (i.e., gauges, instruments, software etc.
used to make the measurements),
- the personnel used to assign a quantity to the characteristics being measured
- measurement system (i.e., the units of measure and the process by which standards are
developed and maintained).
Why is this Necessary?
If the measurements of product and service are to have any meaning, they have to be performed in a
manner that provides results of integrity results others inside and outside the organization can respect
and rely on as being accurate and precise.
How is this Demonstrated?
a. Controlling Measurements
- Knowing what equipment is used for product verification purposes
- Knowing where the equipment is
- Knowing who the current custodian
- Knowing what condition it is in
- Knowing when its accuracy was last checked
- Knowing what checks have been made using the instrument since it was last checked
- Knowing that the measurements made using it are accurate
- Knowing that it is only being used for measuring the parameters for which it was designed
You may not need to know all these things about every device used for product verification but you should
know most of them. This knowledge can be gained by controlling:
- the selection of measuring equipment,
- the use of measuring equipment,
- the calibration of measuring equipment.
The equipment maintenance process should track returns and make provision for tracking down any
maverick equipment, because they could be being used on product acceptance.
b. Measurement Laboratories
In order to maintain the integrity of measurement, physical measurements need to be undertaken in a
controlled environment often referred to as a laboratory. The controlled environment consists of a
workspace (in which the temperature, humidity, pressure, cleanliness, access and the integrity of the
measuring equipment and supporting equipment is controlled) and the personnel competent.
c. Use of Laboratories
Measurements are performed in-house or by external laboratories, both areas should meet the same
standards in order that results are consistently accurate and precise. Wherever the calibration is
performed, the same standards should therefore apply.
IV. Calibrating and verifying measurements
What does this mean?
In a measurement system the physical signal is compared with a reference signal of known quantity.
(The reference signal is derived from measures of known quantity by a process called calibration. The
known quantities are based on standards that in the majority of cases are agreed internationally.)
Traceable to international or national standards an instrument will give the same reading when
measuring a quantity under the same environmental conditions, wherever the measurement is taken.
Calibration process of comparing a physical signal with a reference signal of known quantity (applies to
all measuring equipment used for providing evidence of conformity at any stage through product
realization)
non-physical measurement systems, there is still a need for calibration but we tend to use the
term integrity.
(The only proviso is that they are agreed by those who benefit from the measurements.)
Verification establishing the correctness of a quantity.
(depending on the equipment being examined calibration, verification or both may be necessary.
According to RFI 039, calibration and verification are not mutually exclusive.)
Why is this Necessary?
Two systems used for maintaining the accuracy and integrity of measuring equipment (1) calibration
system - determines the accuracy of measurement and (2) verification system - determines its integrity. If
accuracy is important then the device should be included in the calibration system. If accuracy is not an
issue but the form, properties or function of the equipment is then important that it should be included
in the verification system. With the introduction of the SI system of units, this variation could be
eliminated provided the quantity used to calibrate the measuring equipment was traceable to national or
international standards.
How is this Demonstrated?
a. Calibration of Measuring and Monitoring Equipment
Calibration concerned with determining the values of the errors of a measuring instrument and often
involves its adjustment or scale graduation to the required accuracy.
It is not necessary to calibrate all measuring and monitoring equipment. If such equipment is not used for
determining the acceptability of products and services or process parameters, their calibration is not
essential. However, you should identify such equipment as for Indication Purposes Only if their use for
measurement is possible.
Two types of devices subject to calibration, (1) adjustable device - scale or the mechanism is capable of
adjustment (e.g., micrometer, voltmeter and load cell), and (2) non-adjustable devices wherein a record
of the errors observed against a known standard can be produced which can be taken into account when
using the device (e.g., slip gage, plug gage, surface table, thermometer).
Comparative references are not subject to calibration. They are, however, subject to verification. Such
devices are those which have form or function where the criteria are either pass or fail, i.e., there is no
room for error or where the magnitude of the errors does not need to be taken into account during usage
(this includes software, steel rules or tapes, templates, forming and moulding tools). Verification of such
devices include checks for damage, loss of components, function etc. Use not function determines
the need for calibration.
b. Traceability
- calibration standards for checking the calibration of the working standards
- calibration standards should also be calibrated periodically against national standards
- compatibility between measurements made in different locations using different measuring
devices.
- maintaining traceability enables reliance on obtaining the same result (within the stated limits of
accuracy)

c. Determining Calibration Frequency


ISO 10012 requires that measuring equipment be confirmed at appropriate intervals established on the
basis of stability, purpose and usage. With new equipment it is customary to set the frequency at 12-
month intervals unless recommended otherwise by the manufacturer.
(Often this frequency remains despite evidence during calibration that accuracy and precision are no
longer stable.)
Calibrations should be performed prior to any significant change in accuracy that can be anticipated. If
drift is detected, the intervals of confirmation should be shortened. Conversely, if drift is not detected,
the intervals may be lengthened (if two previous confirmations indicate such action would adversely affect
confidence in the accuracy of the device). Environment, handling, frequency of use and wear are factors
that can affect the stability of devices, (therefore regardless of the calibration results, both previous and
future conditions need to be taken into account). In order to demonstrate you have reviewed the results
and determined the appropriate calibration frequency, provision should be made on the calibration
records for the frequency to be decided at each calibration.

d. Reference Materials
Comparative references devices that are used to verify that an item has the same properties as the
reference.
Certificates should be produced and retained for such reference material so that their validity is known to
those who will use them.
A specification for each reference material should be prepared so that its properties can be verified.

V. Recording the basis for calibration


What does this mean?
Each industry has developed a series of measures by which the quality of its goods and services are
measured and has accordingly developed standards that represent agreed definitions of the measures. In
the service sector involving interrelationships between people, standards become more difficult to define
in quantitative terms and therefore may be defined qualitatively.
Why is this Necessary?
Without a sound basis for comparison, the effort of measurement is wasted
How is this Demonstrated?
- If there is no national standard to calibrate devices, gather together a group of experts within
your company or trade association and establish by investigation, experimentation and debate
what constitutes the standard
- document the basis of your decisions and produce a device or number of devices that can be used
to compare the product or result with the standard using visual, quantitative or other means
- theory and development of the method should be documented and retained as evidence of the
validity of the measurement method

VI. Adjustment of equipment


What does this mean?
Adjustment is only possible with devices that have been designed to be adjustable
Why is this Necessary?
- When a measuring device is verified, it may be found within specification and adjusted if the
parameters have drifted towards the upper or lower limits.
- If the device is found outside specification it can be adjusted or re-adjusted (on subsequent
occasions) within the specified limits.
How is this Demonstrated?
- Adjustments, if made very frequently, may also degrade the instrument
- carry out preventive maintenance in order to keep them in good condition such as cleaning,
testing, inspecting, replenishment of consumables etc.
- Corrective maintenance (restoring a device, after a failure has occurred, to a condition in which it
can perform its required function)
- confirm that the supplier is qualified to perform the calibrations to national standards and to
provide a valid certificate of calibration

VII. Indicating calibration status


What does this mean?
Calibration status position of a measuring device relative to the time period between calibrations
Why is this Necessary?
- system failures are a possibility
- provide a means for checking calibration status
How is this Demonstrated?
- All devices subject to calibration should display an identification label that either directly or
through traceable records, indicates the authority responsible for calibrating the device and the
date when the next calibration is due
- Measuring instruments too small for calibration status labels showing the due date may be given
other types of approved identification. (It is not mandatory that users identify the due date solely
from the instrument itself but they must be able to determine that the instrument has been
calibrated)
- If using serial numbers or special labels, then they need to be traceable to calibration records that
indicate the calibration due date
- Devices that do not fulfil their specification either because part of the device is unserviceable or
due to not performing a full calibration should provide clear indication to the user of the limitation
of such devices

VIII. Safeguarding monitoring and measuring equipment


What does this mean?
Once a device has been calibrated or verified there needs to be safeguards in place to prevent
unauthorized or inadvertent adjustment
Why is this Necessary?
The purpose of this requirement is to ensure that the integrity of the measurements is maintained by
precluding errors that can occur if measuring equipment is tampered with
How is this Demonstrated?
Seals should be applied to the adjustable parts or where appropriate to the fixings securing the container.
If the container can be sealed, then you dont need to protect all the adjustable parts inside. Your
procedures need to specify:
- those verification areas that have restricted access and how you control access;
- the methods used for applying integrity seals to equipment;
- the authority permitted to apply and break the seals;
- the action to be taken if the seals are found to be broken either during use or during calibration

IX. Protection of monitoring and measuring equipment


What does this mean?
Each measuring and monitoring device has a range within which accuracy and precision remain stable
use the device outside this range and the readings are suspect.
Why is this Necessary?
Physical measuring and monitoring devices can be affected by inappropriate handling, maintenance and
storage and thus jeopardize their integrity. Often measuring devices are very sensitive to vibration, dirt,
shock and tampering and thus it is necessary to protect them so as to preserve their integrity.
How is this Demonstrated?
- measuring devices should always be stored in the special containers provided by the
manufacturer
- handling instructions should be provided with the storage case
- when transporting measuring devices, you should provide adequate protection
- for itinerant service engineers, ensure that the instruments they carry are adequately protected
as well as calibrated

X. Action on equipment found out of calibration


What does this mean?
A calibration standard that is found inaccurate within limits for a specified measurement may not be
inaccurate for the range of measurement for which it is being use. Action would be needed only if the
inaccuracies rendered the results obtained from previous use to be inaccurate.
Why is this Necessary?
The validity of the measurement is suspected and therefore an assessment is needed to establish the
consequences if a measurement has been taken with a device that is subsequently found inaccurate.
How is this Demonstrated?
- select measuring devices that are several orders of magnitude more accurate than needed so that
when the devices drift outside the tolerances, they are still well within the required accuracy
- adopt the discipline of re-calibrating devices that have been dropped or are otherwise suspect
before further use
- determine policy in this area paying particular attention to what are claimed to be achieved
- need a procedure for informing the custodians of unserviceable measuring devices and another
for enabling the custodians to track down the products verified using the unserviceable device
and assess the magnitude of the problem
- need a means of ranking problems in order of severity so that you can resolve the minor problems
at the working level and ensure that significant problems are brought to the attention of the
management for resolution

XI. Calibration and verification records


What does this mean?
Applicable to equipment designed and produced by the organization, owned by the organization and
owned by employees and customers when being used for product acceptance
Why is this Necessary?
In order to determine whether the device was inside the prescribed limits when last used. It also permits
trends to be monitored and the degree of drift to be predicted. Calibration records are also required in
order to notify the customer if suspect product or material has been shipped.
How is this Demonstrated?
Records should be maintained not only for proprietary devices but also for devices you have produced
and devices owned by customers and employees.

These records should include where appropriate:


- The precise identity of the device being calibrated or verified (type, name, serial number,
configuration if it provides for various optional features)
- The modification status if relevant (applies to specially designed test equipment and gauges)
- The name and location of the owner or custodian
- The date on which calibration was performed
- Reference to the calibration or verification procedure, its number and issue status
- The condition of the device on receipt
- The results of the calibration or verification in terms of readings before adjustment and readings
after adjustment for each designated parameter, e.g., any out of specification readings
- An impact assessment of any out of specification conditions
- The date fixed for the next calibration or verification
- The permissible limits of error
- The serial numbers of the standards used to calibrate the device
- The environmental conditions prevailing at the time of calibration
- A statement of measurement uncertainty (accuracy and precision)
- Details of any adjustments, servicing, repairs and modifications carried out
- The name of the person performing the calibration or verification
- Details of any limitation on its use
- Notification to the customer if suspect product has been shipped
Clearly not all this information would be presented on one record but the records should be indexed so
that all this information is traceable both forwards and backwards.
Error record produced to enable users to determine the uncertainty of measurement in a particular
range or location and compensate for the inaccuracies when recording the results.

XII. Software validation


What does this mean?
These requirements apply to: (1) production, (2) installation, (3) servicing, (4) design, (5) development,
and (6) operations
Why is this Necessary?
- Software is used increasingly to drive equipment used for measurement or to interpret results.
- The integrity of the software therefore has a bearing on the integrity of the measurement and
therefore needs to be verified prior to use.
- Although software does not degrade or wear out, it can be corrupted such that it no longer does
the job it was intended to.
How is this Demonstrated?
To control software, you need to consider what it is that you need to control:
- use (specifying the software by type designation and version in the development and production
test procedures or a register that relates products to the software that has to be used to verify its
acceptability)
- configuration
- modification (complies with the requirement of standards)
- location (in terms of where it is installed)
- replication and disposal (secure storage and prior authorization routines)

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