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TITLE

DEPTT/
SECTION
QUALITY
ASSURANCE

CONTROL OF MEASURING,
INSPECTION AND TEST EQUIPMENT
RELATED ISO 9001 CLAUSE
4.11

REVIEW & OPERATIONAL


APPROVAL BY

DOCUMENT #.
RP-SP/F-09

ISSUE #.
01

ISSUE DATE
11-10-2012

PAGE #.
1 of 3

ADMINISTRATIVE APPROVAL BY

PREPARED BY

1.0 PURPOSE
1.1 To purpose of this procedure is to develop a system, establish a procedure, provide instructions, and assign responsibilities for
internal and external calibration, identification and maintenance of inspection, measuring and test equipment.
2.0 SCOPE
2.1 THIS PROCEDURE IS APPLICABLE FOR
2.1.1 All laboratory instruments e.g. HPLC, spectrophotometer, pH meter, balances, dissolution apparatus, screw gauge,
vernal caliper, scale etc which are used in the inspection and testing of raw and packaging materials, in process
materials and finished products.
2.1.2 All measuring devices e.g. temperatures gauges, speedometers, pressure gauges, timers etc. which are installed in
manufacturing and packaging equipments and laboratory instruments.
2.1.3 All balances used in the laboratory, stores, warehouse and production areas for weighing and counter verification of
weighed materials.
3.0 RESPONSIBILITY
3.1 QAM is responsible for developing Internal Calibration methods of laboratory instruments and to ensure external calibration in
the absence of internal method.
3.2 ME is responsible for external calibration of all measuring devices and balances in their department as identified in 2.1.2 and
2.1.3. ME will contact with external calibration company month before the calibration date, he will intimate the external
calibrating company.
3.3 Warehouse Officer responsible for internal calibration of balances.
3.4 Warehouse Officer, QAM and PM are responsible to ensure that all the manufacturing, packaging and testing activities are
carried out under controlled conditions and using calibrated instruments and devices.
3.5 ME / QAM is responsible for the overall compliance of this procedure.
4.0 PROCEDURE
4.1 IDENTIFICATION, MEASUREMENT AND SELECTION OF EQUIPMENT
4.1.1 QAM and ME identifies all those inspection, measuring and test equipments / devices of laboratory and plant
(production, packaging and other service areas) respectively whose functions / readings can directly or indirectly affect
the inspection / testing / verification results and ultimately affecting the product quality.

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4.1.2

All inspection, measuring and testing instruments / devices are identified and tagged using the following numbering
scheme
Equipment Name Abbreviation Measuring Device Name Abbreviation Serial Number
e.g. for temperature gauge of blister machine, the following will be the numbering identification

4.1.3 In case of internal calibration, ME and QAM identifies the calibration frequency.
4.1.4 ME and QAM identifies required accuracy and the tolerance limits for external and internal calibration.
4.2 CALIBRATION
4.2.1 Equipment is calibrated in accordance with written instructions (SOPs), unless calibration is simple and obvious.
4.2.2 When applicable, calibration instruction specify for each type of equipment the acceptable limits of temperature,
pressure, humidity, and other environmental conditions that may adversely affect calibration status.
4.2.3 Calibration of inspection, measuring and test equipment is carried out using calibration instruments or standards
(calibrators) certified to have a known relationship to a nationally or internationally recognized standard. This
relationship is identified on the calibration record.
4.2.4 In case of external and internal calibration it is ensured that the calibrator and the celebrant must have the accuracy
difference of 4.1 where such accuracy level is not established particularly in case of internal calibration the calibration
status must be supported by some simple Statistical Science e.g. slope, regression analysis, standard deviation etc.
4.2.5 Equipment that is externally calibrated is required to have a certification that it is likewise traceable to a national /
internal standard. The Maintenance and Quality Control Department maintains calibration records and certificates.
4.2.6 Calibration equipment is labeled with a sticker / tag indicating instrument / device number, accuracy level, the due date
for next calibration. If it is not possible to attach sticker, the equipment is painted with a red dot in a conspicuous
location to indicate that it is exempted from carrying a sticker. Such equipment is traceable to its calibration record
through its serial number or other unique marking.
4.2.7 Equipment with a past-due calibration date or without a calibration sticker (or a red dot) is not used.
4.3 CALIBRATION MASTER LIST
4.3.1 Quality Assurance / Production and Maintenance Department maintain a list of measuring and test equipment. The list
identifies every piece of equipment by its name and type, serial number, location, calibration frequency, last calibration
date, and next calibration due date.
4.4 STORAGE AND MAINTENANCE
4.4.1 Measuring and test equipment is stored in a secured storage area. The equipment is maintained, stored and handled
in such a way as to preserve its accuracy and fitness for use.
4.4.2 Equipment that is out of calibration or otherwise not fit for use is segregated or marked out of order.
4.5 NON CONFORMING EQUIPMENT
4.5.1 When a piece of measuring or test equipment is found to be out of calibration or appears to give inaccurate reading,
the piece is checked. If it is confirmed that the equipment is outside of its specified accuracy limits, Quality Assurance
and Maintenance and the concerned department investigate and assess the validity of test results / measurements for
which the equipment previously was used.
4.5.2 Identification of such equipment, its investigation and conclusions are reported in a non-conformity report in
accordance with System Procedure Control of out-of-specifications product.

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4.1

5.0

EQUIPMENT EXEMPTED FOR CALIBRATION


4.1.1 Inspection and test equipment used in situations where the accuracy of measurements is not important or where the
measurement does not have any relation to the product are exempted from the calibrations requirement. Such
equipment is labeled with stickers / tags of CNR (Calibration Not Required).
4.1.2 Personnel are made aware of the limitations in using un-calibrated equipment.

RELATED DOCUMENTS
5.1 Calibration Equipment Master List.

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