IM-213 MQC Naima Javed ,Assistant Professor IMD

IM-213 MQC

CALIBRATION
Course Instructor:

Naima Javed
Assistant Professor-IMD
NEDUET
 IM-213 MQC Naima Javed ,Assistant Professor IMD

CALIBRATION SYSTEM
 The purpose of calibration is to ensure that various
types of measurement and process equipment
accurately and consistently perform as designed
and intended
 Further, its is also to ensure that equipment
accuracy and consistency remain correlated with
known quantities or values that are commonly
referred to as standards.
 IM-213 MQC Naima Javed ,Assistant Professor IMD

CALIBRATION SYSTEM
1. Calibration
Interval
Prompt
2. Calibration  A calibration system, like type of system is composed
documenta of inputs, processes, outputs and feed back
tion &
History
3. Calibration
Work order Outputs
4. Process
Process
Inputs Calibrated
Equipment Calibration
Equipment
5. Calibration
Equipment
6. Calibration Feedback
Procedure Verification of
7. Calibration measurement
Environment equipment
Specs operation
8. Calibration
Status
Indicators
IM-213 MQC Naima Javed ,Assistant Professor IMD

Calibration Interval Prompt

 The calibration process is initiated in one of
the two ways
1. A piece of malfunctioning equipment is
submitted for repair and calibration,
2. A piece of equipment is identified as being
in need of calibration in accordance with
an established interval
IM-213 MQC Naima Javed ,Assistant Professor IMD

Calibration Interval Prompt

 A calibration interval is a n interval based on

time such as weekly,
monthly,quarterly,semiannually,annually or
biannually.
 A calibration interval may also be an
interval based on cycles of operation, such
as every 1000 uses.
 The actual prompt initiating the calibration
process may be in either electronic or
hardcopy form
IM-213 MQC Naima Javed ,Assistant Professor IMD

Calibration Interval Prompt

 A calibration interval is established for
equipment identified as being
influenced by or characteristic of any of
the following:
1. Importance in process operation.
2. Manufacturer guidelines or
requirements.
3. Historical performance accuracy and
consistency.
IM-213 MQC Naima Javed ,Assistant Professor IMD

Calibration Documentation and

History
 Each piece of equipment with a calibration interval generally
has repair, maintenance, and calibration documentation.
 The information contained in the calibration documentation
and history includes, but it is not limited to,
 identification of calibration procedures,
 a summary of action taken during calibration,
 summary of failure/discrepancies,
 summary of parts replaced,
 identification of calibration technicians who have worked
on the equipment,
 and perhaps any special comments or warnings such as
any particular function that may not have been
calibrated or functions that are inoperable
IM-213 MQC Naima Javed ,Assistant Professor IMD
IM-213 MQC Naima Javed ,Assistant Professor IMD
IM-213 MQC Naima Javed ,Assistant Professor IMD

Calibration Work Order

 A calibration work order is initiated when a
calibration interval is due or when a piece of
equipment is malfunctioning .
 Work order commonly identify :
 where the equipment is located(which may
mean where in the calibration lab it has been
temporarily stored/shelved,or where the
equipment is installed in a process application),
 which calibration procedure are
applicable,support equipment required to
complete the calibration,
 and perhaps the time needed to complete the
calibration process
IM-213 MQC Naima Javed ,Assistant Professor IMD

Process Equipment

 Process equipment refers to the equipment

used in production or service activities.
 It is important to note that process
equipment may be used in process flow
directly, or may be used in measurement &
assessment of process flow, depending on
the application,
IM-213 MQC Naima Javed ,Assistant Professor IMD

Calibration Equipment

 Calibration refers to equipment used

during,or in support of the calibration
process.
 Calibration equipment may be
assemblies or sub assemblies needed to
evaluate the performance of any given
piece of equipment.
IM-213 MQC Naima Javed ,Assistant Professor IMD

Calibration Procedure
 Calibration procedure are the step-by-step
instructions that describe the calibration process
for a given piece of equipment.
 Such procedure are not normally stored with the
equipment ,these procedures reside in the
calibration laboratory.
 Calibration procedures identify all process
equipment models or configurations to which the
procedures apply.
 Calibration technicians have no authority to
deviate from the instructions for any reason,
unless there is a documented cause for
improvement,.
IM-213 MQC Naima Javed ,Assistant Professor IMD

Calibration Environment
Specifications
 It describes the conditions under which calibrations
are to be performed.
 Calibration environment specifications commonly
address cleanliness,temperature,humidy,and vibration
;however,many other factors may need to be
controlled to ensure that a valid calibration is
completed.
IM-213 MQC Naima Javed ,Assistant Professor IMD

Calibration Status Indicators

 As a check and balance in case a calibration
interval prompt is not effective, calibration status
indicators are used.
 Status indicators are color coded stickers or label
attached to equipment that provide status of a
calibration.
 Information on the status indicators includes, the
date of the calibration, the date of the next
calibration, any modes of operation or functions
excluded from the last calibration, special
comments, and who performed the the last
calibration.
IM-213 MQC Naima Javed ,Assistant Professor IMD

Calibration Status Indicators

IM-213 MQC Naima Javed ,Assistant Professor IMD

Calibration Standards

 Calibration standards are known ,highly

accurate ,verifiable quantities used as a
basis of comparison in calibration
process.
 NIST(National Institute of Standard &
Technology) is the custodian of
measurement standards in US.Its
functions are research on measurement,
properties of material and calibration of
reference standards
IM-213 MQC Naima Javed ,Assistant Professor IMD

Calibration Standard
Hierarchy

International Standards

National Standards

Primary Standards

Secondary Standards

Reference Standards

Working Standards

Transfer Standards
IM-213 MQC Naima Javed ,Assistant Professor IMD

Calibration Standard
Hierarchy
1. International Standards:
A standard recognized by international agreement
to serve internationally as the basis for fixing the
value of all other standards of the quantity
concerned.e.g SI Units
2.National Standards:
A standard recognized by an official decision to
serve in a country as a basis for fixing value of all
other standards of the quantity concerned.
Generally a primary standard in a country is also a
primary standard to which other standard are
traceable.
IM-213 MQC Naima Javed ,Assistant Professor IMD

Calibration Standard
Hierarchy
 3.Primary Standards:
•A standard i.e. widely acknowledged as having the
the highest metrological quality and whose value is
accepted without reference to other standards of the
same quantity .
•National Standards are generally primary standards.
 4.Secondary Standards:
A standard whose value is based on comparisons
with some primary standard. Note that a secondary
standard, once its value is established ,can become
a primary standard for some other user.
IM-213 MQC Naima Javed ,Assistant Professor IMD

Calibration Standard
Hierarchy
 5.Reference Standard:
A standard having the highest metrological
quality available at given location from
which the measurements made at that
location are derived
 Working Standard:
A measurement standard not specifically
reserved as a reference standard, which is
intended to verify measurement equipment of
lower accuracy.
IM-213 MQC Naima Javed ,Assistant Professor IMD

Calibration Standard
Hierarchy
 Transfer Standard:
A standard that is the same as a reference
standard except that its is used to
transfer a measurement parameter from
one organization to another for
traceability purposes.
IM-213 MQC Naima Javed ,Assistant Professor IMD

Equipment Traceability
 Traceability is a process intended to quantify a
laboratory’s measurement uncertainty in
relationship to national standards.
 Traceability is based on analysis of error
contributions present in each of the
measurement transfers:the calibration of the
laboratory’s reference standards by the NIST,
the measurement made in calibration transfer
in lab,and the measurements made on a
product.
 Such traceability may be as simple as retention
of certificates and reports of calibration or as
complex as reproduction of the analyses
demonstrating the uncertainties claimed for
the measurements.
IM-213 MQC Naima Javed ,Assistant Professor IMD

ISO IEC /2017

6.5 Metrological traceability
 6.5.1 The laboratory shall establish and maintain
metrological traceability of its measurement results by
means of a documented unbroken chain of
calibrations, each contributing to the measurement
uncertainty, linking them to an appropriate reference.
“
 NOTE 1 In ISO/IEC Guide 99, metrological traceability
is defined as the
“property of a measurement result whereby the result
can be related to a reference through a documented
unbroken chain of calibrations, each contributing to the
measurement uncertainty”.
IM-213 MQC Naima Javed ,Assistant Professor IMD

Out-of-Calibration Effects

 The effects of out-of-calibration equipment

cause stakeholders to believe that
1.The equipment is calibrated and functioning
properly when it is not, or
2. The equipment appears to fail calibration when it
is, in fact, functioning correctly.
IM-213 MQC Naima Javed ,Assistant Professor IMD

Out-of-Calibration Effects

At a minimum, procedures for dealing with an out-

of-calibration event or discovery include the
following:
1. Identification of the out-of-calibration condition
i.e. error type is identified.
2. Determination of the magnitude of the condition
(i.e., how far out of calibration was the equipment?)
IM-213 MQC Naima Javed ,Assistant Professor IMD

Out-of-Calibration Effects
3.
Assessment of when the out-of-
calibration condition occurred
4. Quantification of the amount of
product/service delivery
produced/delivered during the out-of-
calibration condition
5. Evaluation of product or service delivery
status (i.e., was any product produced or
any service provided to customers during
the out-of-calibration condition?)
6. Identification of who is authorized to
manage the containment efforts