1565 Bustard Road
Lansdale, PA 19446
Phone: 610‐287‐3433 Fax: 610‐287‐0233
Web: www.integratedservicesolutions.com
Document Type: Calibration Work Instructions Effective Date: 06 Aug 2018
TM Title: Mass Comparison Calibration [WHT‐CAL]
ID: ISO‐CWI‐3152 Revision: 6.00 Page: 1 Of 21
Calibration Work Instruction
Mass Comparison Calibration
CWI
For the Metrology Laboratory
THIS DOCUMENT MAY NOT BE REPRODUCED WHOLLY OR IN PART WITHOUT THE EXPRESSED WRITTEN PERMISSION OF
INTEGRATED SERVICE SOLUTIONS, INC.
AN ISO 9001:2015 REGISTERED COMPANY
© COPYRIGHT 2018 ‐ 2021, CONFIDENTIAL & PROPRIETARY
INTEGRATED SERVICE SOLUTIONS, INC., AN ISO 9001:2015 REGISTERED COMPANY
1565 Bustard Road
Lansdale, PA 19446
Phone: 610‐287‐3433 Fax: 610‐287‐0233
Web: www.integratedservicesolutions.com
Document Type: Calibration Work Instructions Effective Date: 06 Aug 2018
TM Title: Mass Comparison Calibration [WHT‐CAL]
ID: ISO‐CWI‐3152 Revision: 6.00 Page: 2 Of 21
Table of Contents
1. Purpose ................................................................................................................................ 3
2. Scope ................................................................................................................................... 3
3. Records ................................................................................................................................ 4
4. Responsibilities ................................................................................................................... 4
5. Definitions ............................................................................................................................ 5
6. References ........................................................................................................................... 7
7. Conversion Factors and Formulas .................................................................................. 10
8. General Safety Issues ....................................................................................................... 11
9. Calibration Frequency ...................................................................................................... 11
10. Materials and Equipment ............................................................................................... 11
11. Calibration Procedure .................................................................................................... 15
12. Equipment GLP: ............................................................................................................. 16
13. Environment GLP: .......................................................................................................... 17
14. ‘As Found’ Condition Determination: .......................................................................... 19
15. ‘As left’ Condition determination: ................................................................................ 20
16. Final: Calibration Completion / Data Submittal: .......................................................... 20
17. End of Procedure ........................................................................................................... 20
18. Revision History ............................................................................................................. 21
© COPYRIGHT 2018 ‐ 2021, CONFIDENTIAL & PROPRIETARY
INTEGRATED SERVICE SOLUTIONS, INC., AN ISO 9001:2015 REGISTERED COMPANY
1565 Bustard Road
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Phone: 610‐287‐3433 Fax: 610‐287‐0233
Web: www.integratedservicesolutions.com
Document Type: Calibration Work Instructions Effective Date: 06 Aug 2018
TM Title: Mass Comparison Calibration [WHT‐CAL]
ID: ISO‐CWI‐3152 Revision: 6.00 Page: 3 Of 21
Mass Comparison Calibration [WHT-CAL]
1. Purpose
1.1. The following are the purposes of this Work Instruction:
1.1.1. To standardize Integrated Service Solutions, Inc., processes used by technicians to
perform preventive maintenance & calibration of instruments and devices included
in the scope of this procedure.
1.1.2. To secure sufficient documentation for compliance with applicable regulating
agencies and client requirements including, but not limited to: Current Good
Manufacturing / Laboratory / Tissue / Engineering Practices (cGXP); United States
Pharmacopoeia requirements (i.e. – USP); Current industry standards.
2. Scope
2.1. The scope of this procedure includes, but is not limited to the test, verification &
calibration of mass determinations (i.e. weights), as the following examples;
2.1.1. 1 mg to 25 Kg Mass; ASTM Class 1, 2, 3, 4, 5, 6, 7
2.1.2. 1 mg to 25 Kg Mass; OIML Class E2, F1, F2, M1, M2 and M3
2.1.3. 1 mg to 25 Kg Mass; NIST Class F
2.1.4. Nonstandard Mass Measurements from 1 mg to 30 Kg
2.1.5. US (English) Equivalent Masses converted to SI units
Figure 2-1, Typical Masses
2.2. The scope of this procedure excludes the calibration of:
2.2.1. ASTM Class 0, OIML Class E1, or any class/type over 30 Kg
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INTEGRATED SERVICE SOLUTIONS, INC., AN ISO 9001:2015 REGISTERED COMPANY
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Phone: 610‐287‐3433 Fax: 610‐287‐0233
Web: www.integratedservicesolutions.com
Document Type: Calibration Work Instructions Effective Date: 06 Aug 2018
TM Title: Mass Comparison Calibration [WHT‐CAL]
ID: ISO‐CWI‐3152 Revision: 6.00 Page: 4 Of 21
3. Records
3.1. All records and data submittals will comply with ISO‐QSP‐2010 General Field Service and
Calibration Practices.
3.2. Retention of all original records and data submittals is the responsibility of the Client and
the subject to the Client’s internal storage procedures.
4. Responsibilities
4.1. The responsibilities of the Client and Integrated Service Solutions, Inc. are defined fully in
ISO‐QSP‐2010 General Field Service and Calibration Practices, in summary;
NOTE: No deviations from authorized procedures are to be made unless the deviation has been
documented, technically justified, and accepted by the client. Refer to ISO‐QSP‐2005.
4.2. Integrated Service Solutions, Inc.
4.2.1. Integrated Service Solutions, Inc. is responsible for the following;
4.2.1.1. To provide qualified service personnel to perform all tasks defined in this
procedure. Personnel qualifications may be based upon formal and/or on‐
the‐job training.
4.2.2. To provide all necessary documentation to the client in a timely manner and
compliant with client requirements.
4.2.3. To provide all standards and equipment as defined in the project service proposal /
agreement.
4.3. Client
4.3.1. The Client is responsible for the following;
4.3.1.1. To designate a site contact(s) for Integrated Service Solutions, Inc. who is
responsible for all communications (verbal and written) between Company
Personnel and the Client. This includes, but is not limited to scheduling of all
required work, resolution of conflicts, completion / review of all necessary
paperwork.
4.3.1.2. To ensure that all Client site safety and other required contractor procedures
are disclosed to Company Personnel and that all service personnel assigned
to the site have received formal training on those procedures.
4.3.1.3. To ensure a safe physical operating environment for all service personnel.
4.3.1.4. When applicable, to provide operator assistance for equipment of devices
that requires calibration.
4.3.1.5. To provide all standards and equipment as defined in the project service
proposal / agreement.
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INTEGRATED SERVICE SOLUTIONS, INC., AN ISO 9001:2015 REGISTERED COMPANY
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Phone: 610‐287‐3433 Fax: 610‐287‐0233
Web: www.integratedservicesolutions.com
Document Type: Calibration Work Instructions Effective Date: 06 Aug 2018
TM Title: Mass Comparison Calibration [WHT‐CAL]
ID: ISO‐CWI‐3152 Revision: 6.00 Page: 5 Of 21
4.3.1.6. To provide all necessary documentation (i.e. – manuals, SOPs, etc) to
complete all proposed services.
4.3.1.7. To retain all original completed documentation by Integrated Service
Solutions, Inc. via internal storage procedures.
5. Definitions
5.1. Accuracy class: Class designation of a weight or weight set which meets certain
metrological requirements intended to maintain the mass values within specified limits.
5.2. ANSI/ASTM Class 0: Used as primary reference standards for calibrating other reference
standards and weights.
5.3. ANSI/ASTM Class 1: Can be used as a reference standard in calibrating other weights and
is appropriate for calibrating high precision analytical balances with a readability as low as
0.1 mg to 0.01 mg.
5.4. ANSI/ASTM Class 2: Appropriate for calibrating high‐precision top loading balances with a
readability as low as 0.01 g to 0.001 g.
5.5. ANSI/ASTM Class 3: Appropriate for calibrating balances with moderate precision, with a
readability as low as 0.1 g to 0.01 g.
5.6. ANSI/ASTM Class 4: For calibration of semi‐analytical balances and for student use.
5.7. ANSI/ASTM Class 5: For student laboratory use.
5.8. ANSI/ASTM Class 6: Student brass weights are typically calibrated to this class. This class
also meets the specifications of OIML R 111 Class M2.
5.9. ANSI/ASTM Class 7: For rough weighing operations in physical and chemical laboratories,
such as force measuring apparatus.
5.10. Austenitic: Pertaining to or describing a solid solution in iron of carbon and sometimes
other solutes that occur as a component of steel under certain conditions. Austenitic
stainless steels usually offer many advantages such as increased strength, corrosion
resistance, lower magnetic susceptibility, and desirable mechanical and magnetic
properties.
5.11. Balance: Instrument indicating apparent mass that is sensitive to the following forces;
Gravity, Air Buoyancy, and Magnetism. If magnetic effects are negligible, i.e. the
permanent magnetization of the weight and the magnetic susceptibility are sufficiently
small, and the balance is calibrated with reference weights of well known mass, the
balance can be used to indicate the conventional mass of a body under conventionally
chosen conditions.
5.12. Calibration: The act of determining the mass difference between a standard of a known
mass value and an “unknown” test weight or set of weights. The process uses a
comparison method and a series of calculations to establish the mass value and
conventional mass value of the “unknown” and determines a quantitative estimate of the
uncertainty to be assigned to the measurement process as well as the mass or
conventional mass value for the “unknown.”
5.13. Calibration Certificates: IAW the OIML Recommendations a calibration or verification
certificate shall state, as a minimum: the conventional mass of each weight, an indication
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INTEGRATED SERVICE SOLUTIONS, INC., AN ISO 9001:2015 REGISTERED COMPANY
1565 Bustard Road
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Phone: 610‐287‐3433 Fax: 610‐287‐0233
Web: www.integratedservicesolutions.com
Document Type: Calibration Work Instructions Effective Date: 06 Aug 2018
TM Title: Mass Comparison Calibration [WHT‐CAL]
ID: ISO‐CWI‐3152 Revision: 6.00 Page: 6 Of 21
of whether a weight has been adjusted prior to calibration, its expanded uncertainty, and
the value of the coverage factor, k.
5.14. Comparison: Method of measurement based on comparing the value of a quantity to be
measured with a known value of the same quantity.
5.15. Conventional Mass: The conventional value of the result of weighing in air, in accordance
to International Recommendation OIML R 33. For a weight taken at 20º C, the
‐3
conventional mass is the mass of a reference weight of a density of 8000 kg/m , which it
‐3
balances in air density of 1.2 kg/m .
5.16. Correction: Mass values are traditionally expressed by two numbers, one being the
nominal mass of the weight and the second being a correction. The mass of the weight is
the assigned nominal value plus the assigned correction. Positive corrections indicate that
the weight embodies more mass than is indicated by the assigned nominal value.
M
5.17. Density of a body: Mass divided by volume, given by the formula:
V
5.18. International Prototype Kilogram: The platinum‐iridium cylinder maintained at the
International Bureau of Weights and Measures (BIPM), at Sevres, Frances with an
internationally accepted defined mass of 1 kg with zero uncertainty.
5.19. Linearity: Plus or minus deviation from the theoretically straight‐lined course of two
interdependent values. In balances, this expression is applied to the plus or minus
deviation of the indicated measurement value from the true value of the load.
5.20. Mass in a Vacuum: The mass of a weight as if it were measured in a vacuum. Also known
as True Mass.
5.21. NIST Class F: Primarily used to test commercial weighing devices by state and local
weights and measures officials, device installers and service technicians. Class F weights
may be used to test most accuracy Class III scales, all scales of Class IIIL or IIII, and scales
not marked with a class designation.
5.22. Nominal Mass: The mass value as marked on a weight.
5.23. OIML Class E1: Used as primary reference standards for calibrating other reference
standards and weights.
5.24. OIML Class E2: Can be used as a reference standard in calibrating other weights and is
appropriate for calibrating high precision analytical balances with a readability as low as
0.1 mg to 0.01 mg.
5.25. OIML Class F1: Appropriate for calibrating high‐precision top loading balances with a
readability as low as 0.01 g to 0.001 g.
5.26. OIML Class F2: For calibration of semi‐analytical balances and for student use.
5.27. OIML Class M1, M2, M3: Economical weights for general laboratory, industrial,
commercial, technical and educational use. Typically fabricated from cast iron or brass.
Class M2 is commonly used for student brass weights.
5.28. Readability: The mass value of the smallest scale or digital interval displayed by the
weighing machine.
5.29. Reference Standard: A standard, generally of the highest metrological quality available at
a given location, from which measurements made at that location are derived.
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Phone: 610‐287‐3433 Fax: 610‐287‐0233
Web: www.integratedservicesolutions.com
Document Type: Calibration Work Instructions Effective Date: 06 Aug 2018
TM Title: Mass Comparison Calibration [WHT‐CAL]
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5.30. Repeatability: A measure of a weighing machine’s ability to display the same result when
repeated measurements are made under the same weighing conditions.
5.31. Traceability: Property of the result of a measurement or the value of a standard whereby
it can be related to stated references, usually national or international standards, through
an unbroken chain of comparisons all having stated uncertainties. In other words, in order
to establish traceability there must be an unbroken and valid relationship to some
nationally or internationally recognized standard. A standard itself cannot really be
traceable, but the value assigned to it can.
5.32. Tolerance: The maximum amount by which the conventional mass of the weight is
allowed to deviate from the assigned nominal value. Also defined as Maximum
Permissible Error.
5.33. UltraClass: UltraClass weights (made by Troemner) are the most precise two‐piece
weights available with weight tolerances 50% greater than ANSI/ASTM E617 Class 1
tolerances, these weights are used by the Company as reference standards for calibrating
other masses.
5.34. USP: Abbreviation for ‘United States Pharmacopoeia’
5.35. UUT: Abbreviation for ‘Unit‐Under‐Test’; It is the instrument or device undergoing the
calibration.
5.36. Uncertainty: Parameter associated with the result of a measurement that characterizes
the dispersion of the values that could reasonably be attributed to the measurement. This
is the range of values within which the true value is estimated to lie. In other words, the
uncertainty is a measure of how confident you are in the accuracy of the results resulting
from a measurement. Typically reported at a 95% confidence level.
5.37. U.S. National Prototype Standard: Platinum‐Iridium kilogram identified as K20,
maintained at the National Institute of Standards and Technology (NIST), with a value
assigned relative to the International Prototype Kilogram.
5.38. Verification: The use of measurement & test equipment (M&TE) or any other suitable
means to verify the accuracy or operation of a UUT. No adjustments are made to the
UUT, nor is the calibration due date of the UUT changed. Verifications may be performed
with a TAR < 1:1.
5.39. Weight (Mass standard): An object representing a specific mass, regulated in regard to its
physical and metrological characteristics: shape, dimension, material, surface quality,
nominal value, and maximum permissible error.
6. References
The following reference material was utilized in the authoring of this procedure:
6.1. 21 CFR Part 820 Medical Devices: Current Good Manufacturing Practice (CGMP); Final
Rule, 07 Oct 1996
6.2. ANSI/ISO/IEC 17025:2005: General Requirements for the Competency of Testing and
Calibration Laboratories – This guide sets out the general provisions which a laboratory
must address to carry out specific calibrations or tests. ISO/IEC 17025 provides the
laboratory direction for the development and implementation of a fundamental quality
management system.
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Document Type: Calibration Work Instructions Effective Date: 06 Aug 2018
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6.3. ANSI/NCSL‐Z540‐1‐1994: Calibration Laboratories and Measuring and Test Equipment‐
General Requirement (ANSI/NCSL) – This standard provides a mechanism for promoting
confidence in calibration laboratories and measuring and test equipment when it can be
shown that they are operated in compliance with its requirements.
6.4. ASTM E 617‐ 13: Standard Specification for Laboratory Weights and Precision Mass
Standards: This specification covers various classes of weights and mass standards used in
laboratories ranging from Class 000 to Class 7. Maximum Permissible Errors (formerly
tolerances) and design restrictions for each class are described in order that both
individual weights or sets of weights can be chosen for appropriate applications. This
specification also recognizes the International Standard Recommendation for Mass
Metrology, OIML R111 that describes OIML classes E1, E2, F1, F2, M1, M2, and M3.
6.5. Calibration System Specification: National Conference of Standards Laboratories (NCSL)
Documents No. NCSL RP‐4, circa 1971
nd
6.6. Calibration Philosophy in Practice: Fluke Corporation, 2 Edition, ISBN 0‐9638650‐0‐5,
1994
6.7. Instrumentation Symbols and Identification: ANSI/ISA Standard No. ANSI/ISA‐5.1‐1984
(R1992)
6.8. Measurement and Calibration Requirements: For Quality Assurance to ISO 9000, ISBN
No. 0 471 976857, 1997
6.9. NCSL Glossary of Metrology Related Terms: National Conference of Standards
Laboratories (NCSL) Documents, Current Issue
6.10. NIST Handbook 105‐1: Specifications and Tolerances for Field Standard Weights – These
specifications and tolerances are specific for reference and field standard weights (NIST
Class F). This document sets minimum requirements for standards used primarily to test
commercial or legal for trade weighing devices for compliance with NIST Handbook 44.
These devices include but are not limited to delicatessen scales, jewelry scales, postal and
parcel post scales and dairy product test scales. This specification permits the use of a
weight at its nominal value in normal testing operations, where the tolerance on the item
under test is at least three times as great as the tolerance of the weight. This specification
also specifies the design, marking, adjusting cavities, and density of these weights. Any
variation in design from Handbook 105‐1 must be submitted to NIST for approval.
6.11. NIST Handbook 44: Specifications, Tolerances, and Other Technical Requirements for
Weighing and Measuring Devices ‐ This publication sets forth the specifications,
tolerances, and other technical requirements for weighing and measuring devices.
Handbook 44 is published in its entirety each year following the Annual Meeting of the
National Conference on Weights and Measures. All of the specifications, tolerances, and
other technical requirements of this booklet are recommended by the National
Conference on Weights and Measures for official promulgation and use by the states in
exercising their control of commercial weighing apparatus.
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6.12. NVLAP Handbook 150: Procedures and General Requirements ‐ Outlines the quality
system and all of the procedures required in order to be NVLAP accredited. NVLAP
Handbook 150 also contains all requirements specified in ISO/IEC 17025.
6.13. OIML R‐111‐1:2004 (e): This international document describes the physical characteristics
and metrological requirements of reference standard weights with recommendations for
seven classes of weights (OIML Classes E1, E2, F1, F2, M1, M2, M3) in tiers of uncertainty.
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Document Type: Calibration Work Instructions Effective Date: 06 Aug 2018
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7. Conversion Factors and Formulas
Figure 7‐1, Mass Unit Conversions
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8. General Safety Issues
8.1. The following are general safety issues. Not all may apply to this procedure directly.
8.1.1. Wear the proper safety attire. This may include, but is not limited to: safety glasses,
safety shoes, hard hats, full‐face shields, lab coats/aprons, and gloves.
8.1.2. Inspect area for potential hazardous conditions (i.e. – wet floors, exposed electrical
wires, loosely hanging overhead equipment, other personnel working in the area,
etc.).
8.1.3. Ensure that UUT Instruments used with bio‐hazardous materials have been
decontaminated properly in accordance with local protocols by the Client, before
attempting service.
8.1.4. Refer to General Safety Practices: ISO‐QSP‐2117 for all other safety‐related issues.
9. Calibration Frequency
9.1. This procedure is recommended to be performed minimally every 12 months, or
whenever changes or repairs have been made that may affect the accuracy of the
measurement system. Actual calibration / preventive maintenance intervals are to be
defined by the Client.
10. Materials and Equipment
10.1. The following materials and equipment may be necessary for the completion of this
procedure:
Table 10‐1
Test Equipment Type / Material Required Accuracy (if applicable)
Mass Comparators; Mettler Toledo UMX5, AX206, Best Measurement Uncertainties
AX2005, KA30‐3/P IAW 17025 Scope of accreditation
Mass Set; ASTM Class 0 or Troemner Ultra‐Class Best Measurement Uncertainties
NAVLAP certified IAW 17025 Scope of accreditation
Thermistor Thermometer; Hart Scientific
‘Blackstack’ Model 8‐channel scanner & probe ± 0.10°C, 15 to 25°C Ambient Range
assembly w/readout & computer interface
Barometric Pressure monitor; Vaisala PTB220 ± 0.05 mm Hg, 800 to 1200 mmHgA
Barometer
Temperature & Humidity monitor: Vaisala HMT333 ± 1.0 % RH, 20 to 80 %RH
Automated Mass Measurement Software: MTL, Meets OIML R111 data calculation requirements
LLC AMMS version 2.5 Base Software Package
Note: All test equipment is to be NIST traceable and currently in a calibrated condition.
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Maximum Permissible Errors
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INTEGRATED SERVICE SOLUTIONS, INC., AN ISO 9001:2015 REGISTERED COMPANY
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Lansdale, PA 19446
Phone: 610‐287‐3433 Fax: 610‐287‐0233
Web: www.integratedservicesolutions.com
Document Type: Calibration Work Instructions Effective Date: 06 Aug 2018
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Phone: 610‐287‐3433 Fax: 610‐287‐0233
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11. Calibration Procedure
11.1. The following sections document the recommended calibration protocols for the
instrument(s) in question.
11.2. Pre‐inspection
11.3. The UUT Mass (es) and their associated storage containers should be allowed to
acclimatize for 24 hours in the Mass Laboratory prior to initial inspection.
11.3.1. The UUT Mass must not be placed on soiled surfaces, knocked, dropped, or
scrapped.
11.3.2. The UUT Mass storage container should be opened and placed as near to the Mass
Comparators as reasonable possible prior to beginning services; the masses will be
allowed to further stabilize ½ hour prior to beginning calibration measurements.
11.3.3. Verify that the UUT Mass is placed on a solid, vibration‐free workplace, and located
away from sources of temperature fluctuation and drafts (as applicable).
11.3.4. Inspect the UUT Mass for any abnormalities (i.e. – physical damage, worn/missing
parts, limited movement of parts, etc.).
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11.4. Make sure the workplace is free from oil, and adequately ventilated for chemical fumes
(for cleaning).
11.5. The UUT Mass should not be subject to a sudden change in temperature, as condensation
may accumulate in the adjusting cavity.
11.6. The workplace should be well lit for visual inspection.
11.7. Document all abnormalities on the ‘Calibration Data Report’ for the UUT Mass.
NOTE
Do not perform any internal calibration adjustments
prior to taking as found test data ( section 13.0)
11.8. Cleaning GLP:
11.8.1. Cleaning GLP of UUT masses will be performed in accordance with OIML R‐111‐
1:2004(e) guidelines as follows;
11.8.1.1. It is important to clean weights before any measurements are made because
the cleaning process may change the mass of the weight.
11.8.1.2. Cleaning should not remove any significant amounts of weight material.
11.8.1.3. Weights should be handled and stored in such a way that they stay clean.
11.8.1.4. Before calibration, dust and any foreign particles shall be removed.
11.8.1.5. Care must be taken not to change the surface properties of the weight (i.e.
by scratching the weight).
11.8.1.6. If a weight contains significant amounts of dirt that cannot be removed by
the methods cited above, the weight or some part of it can be washed with
1
clean alcohol, distilled water or other solvents.
11.8.1.7. Weights with internal cavities should normally not be immersed in the
solvent to avoid the possibility that the fluid will penetrate the opening.
11.8.1.8. If there is a need to monitor the stability of a weight in use, the mass of the
weight should, if possible, be determined before cleaning.
12. Equipment GLP:
12.1. The Metrology Mass Comparators must be placed on a stable platform free from the
effects of vibration. The most common type of setup involves placing the instrument onto
a balance table that is constructed of marble or granite.
12.2. Never use a balance or scale as soon as it is turned on. The internal electronic
components need to stabilize and “warm‐up” for at least twenty‐four hours once the
1
After extensive cleaning with solvents, the UUT Mass must be stabilized at least 24 hours before
retesting.
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TM Title: Mass Comparison Calibration [WHT‐CAL]
ID: ISO‐CWI‐3152 Revision: 6.00 Page: 17 Of 21
equipment has been energized. The Metrology Mass Comparators must be plugged into
AC Power twenty‐four hours a day, seven days a week.
12.3. Never use a Metrology Mass Comparators that has been idle for several hours without
first “exercising it” and calibrating it. A balance is exercised by repeatedly placing and
removing weights from the balance pan. The AMMS software ‘Warming’ feature will
perform this function automatically.
12.4. When weights are not in use, store them in the case(s) in which they are supplied. If the
weights were not supplied with a case, either purchase one or use a clean container to
protect the surface(s) – this will keep airborne particles from getting on your weights
between uses. Weights should be in thermal equilibrium with the balance so store
weights near the Comparators – this assures our weights are in thermal equilibrium with
the Metrology Mass Comparators producing a better measurement.
13. Environment GLP:
13.1. The more stable the Mass Metrology environment, the better our measurement results.
Changes in temperature, pressure and humidity affect balance performance and weight
stability. Ideal room conditions are 20.0 °C with a relative humidity between 45% and
60%. Fluctuations in temperature should not exceed 1.0 °C per hour. Humidity
fluctuations should not exceed 10% per hour.
13.2. Balances should not be placed in close proximity to anything that shakes, vibrates, or stirs
violently. Avoid placing any centrifuges, vortexers, or shakers in the Mass Metrology
Laboratory.
13.3. Do not place Mass Comparators near anything that generates heat. Heat will cause the
balance chamber to warm and due to the effects of the thermal expansion introduce
large errors into your measurement. Do not place the Mass Comparators near a window.
Sunlight can penetrate the window, warm the balance chamber at different rates during
the day, and affect the quality of the work.
13.4. Avoid placing the Mass Comparators near sources of drafts, extreme air currents, or near
air conditioning vents. These positions can cause our readings to be unstable and can
dramatically cool the balance chamber when the air‐conditioning system begins to run.
13.5. The Mass Metrology Measurement environment should be clean and free of excessive
contaminants. Contaminants such as dirt and grease can adversely affect the weight of an
object.
13.6. Operator GLP:
13.6.1. Never touch a weight with your bare hands! Oils and contaminants from your hand
will be transferred to the weight and introduce a significant error. It is
recommended that all weights be manipulated with gloved hands or forceps. The
two types of gloves that are commonly used and accepted are either latex (powder‐
less) or cotton.
13.6.2. Avoid any metal to metal contact when handling or storing weights – this will cause
scratches that may introduce error. All weight forceps and weight lifters should be
either nonmetallic (plastic or wood) or if metal, covered with a soft protective
coating or material to avoid scratches.
© COPYRIGHT 2018 ‐ 2021, CONFIDENTIAL & PROPRIETARY
INTEGRATED SERVICE SOLUTIONS, INC., AN ISO 9001:2015 REGISTERED COMPANY
1565 Bustard Road
Lansdale, PA 19446
Phone: 610‐287‐3433 Fax: 610‐287‐0233
Web: www.integratedservicesolutions.com
Document Type: Calibration Work Instructions Effective Date: 06 Aug 2018
TM Title: Mass Comparison Calibration [WHT‐CAL]
ID: ISO‐CWI‐3152 Revision: 6.00 Page: 18 Of 21
13.6.3. Place the weight or sample near the center of the balance pan. A small offset from
center can have a pronounced effect and introduce undue variation.
13.6.4. Take special care not to breathe onto the weight or into the balance chamber. Back
away from the instrument. This will prevent any thermal transfer of heat from your
breath or body to the balance, the weight or sample.
13.6.5. Time your measurements. Consistent sample times will provide more consistent
measurements.
13.7. Measurement of the Density:
13.7.1. Currently Density determination is not an OIML or ASTM requirement for
subsequent or periodic verification (Calibration) of UUT Mass.
13.7.2. Estimates of the Density of the UUT Mass will be obtained using method F, of OIML
R 111‐1:2004(e), and table B‐7 of that reference standard.
13.7.3. The company will not perform density determination on any Client Product
submitted with any other method except method F because of the danger of
damage to the UUT Mass.
13.8. Measurement of the magnetic susceptibility:
13.8.1. Currently Magnetic Susceptibility is not an OIML or ASTM requirement for
subsequent or periodic verification (Calibration) of UUT Mass.
13.8.2. The company will not perform this testing on any Client Product submitted because
of the danger of permanent magnetism of the UUT.
13.9. Basic Test GLP Configuration:
13.9.1. Individual UUT Masses or Mass Sets requiring Calibration are to be calibrated at a
minimum of one set point (1SP) per mass included in set, reporting the conventional
mass value.
13.9.2. The Mass Comparison Methods to be employed will be the either the modified ABA
or ABBA method, performed on the MTL Automated Mass Measurement System
(AMMS). See annex 2 of OIML R 111‐1:2004(e) for a complete description of the
comparison method.
13.9.3. The Comparison Methods ABA SW & ABBA SW is not necessary due to the low
uncertainty component of the Mass Comparators, and will not be required to
perform measurements.
13.9.4. The ABBA method should be employed when required to improve the TUR for OIML
class E2 weights.
13.9.5. The ABA method should be employed for OIML class F1 weights and lower echelon
weight classes.
13.9.6. The ABBA method should be employed when required to improve the TUR for ASTM
type Class 1 weights.
© COPYRIGHT 2018 ‐ 2021, CONFIDENTIAL & PROPRIETARY
INTEGRATED SERVICE SOLUTIONS, INC., AN ISO 9001:2015 REGISTERED COMPANY
1565 Bustard Road
Lansdale, PA 19446
Phone: 610‐287‐3433 Fax: 610‐287‐0233
Web: www.integratedservicesolutions.com
Document Type: Calibration Work Instructions Effective Date: 06 Aug 2018
TM Title: Mass Comparison Calibration [WHT‐CAL]
ID: ISO‐CWI‐3152 Revision: 6.00 Page: 19 Of 21
13.9.7. The ABA method should be employed for ASTM class 3 weights and lower echelon
weight classes.
13.9.8. Refer to The AMMS Instruction Manual, ISO‐MWI‐3346 for specific work
instructions to be followed during the calibration process.
13.10. Correction Factor:
13.10.1. The standard set correction factor is received by the vendor. It is input by the
Mass Technician and then verified by Quality Assurance. Input verification is kept
with the asset file.
14. ‘As Found’ Condition Determination:
14.1. The AMMS Software will record the measured value(s) for each UUT Mass and the
Reference Standard Mass on the calibration data report accordingly. Standard Value will
be recorded in the applicable ‘Standard’ fields and the UUT Certified Value will be
recorded in the applicable ‘As Found’ field, by the AMMS software.
14.1.1. Compare the noted deviations from the ‘As Found’ test data taken to the UUT
tolerance specifications.
14.1.2. Depending on the As‐found condition, the UUT may need to be replaced, optimized
or adjusted before collecting the ‘as‐left data’.
14.1.3. Repeat steps 13.1 thru 13.9 for each Set Point required.
14.1.4. Refer to ISO‐QSP‐2015 for specific procedural instructions.
14.2. Calibration Adjustment:
14.2.1. If UUT Mass fails, then the Metrology Technician should refer to the applicable
adjustment instructions to see if any steps can be taken to correct the failed
condition.
14.2.2. If steps cannot be taken to correct the failed condition, then the technician should
determine a correction factor for the lens/reticule combination that failed;
14.2.3. Original as found condition should be noted on the UUT Calibration / Preventive
Maintenance Data Report, and then record the final as left condition with correction
factor applied.
14.3. Adjustment of OIML Class E weights:
14.3.1. Weights shall be adjusted by abrasion, grinding or any other appropriate method.
The surface requirements shall be met at the end of the process. Weights greater
than 50 kg with an adjusting cavity may be adjusted with the same material from
which they are made.
14.4. Adjustment of OIML Class F weights:
14.4.1. Solid weights shall be adjusted by abrasion, grinding or any other appropriate
method that does not alter the surface. Weights with adjusting cavities shall be
adjusted with the same material from which they are made or with stainless steel,
brass, tin, molybdenum or tungsten.
© COPYRIGHT 2018 ‐ 2021, CONFIDENTIAL & PROPRIETARY
INTEGRATED SERVICE SOLUTIONS, INC., AN ISO 9001:2015 REGISTERED COMPANY
1565 Bustard Road
Lansdale, PA 19446
Phone: 610‐287‐3433 Fax: 610‐287‐0233
Web: www.integratedservicesolutions.com
Document Type: Calibration Work Instructions Effective Date: 06 Aug 2018
TM Title: Mass Comparison Calibration [WHT‐CAL]
ID: ISO‐CWI‐3152 Revision: 6.00 Page: 20 Of 21
14.5. Adjustment of OIML Class M weights:
14.5.1. Thin sheet and wire weights from 1 mg to 1 g shall be adjusted by cutting, abrasion
or grinding. Cylindrical weights which do not have cavities shall be adjusted by
grinding. Weights which have an adjusting capacity shall be adjusted by adding or
removing dense, metallic material such as lead shot. If no more material can be
removed, they may be adjusted by grinding.
14.6. Adjustment of OEM (non‐OIML) weights & fixtures:
14.6.1. All calibration adjustments are to be completed as per manufacturer’s
instructions/documentation.
14.6.2. Document in the comments section of the UUT Calibration / Preventive
Maintenance Data Report any adjustments that were made to the UUT.
15. ‘As left’ Condition determination:
15.1. Collect ‘As Left’ Data as applicable (reference step 13 above).
15.2. Compare the noted deviations from the ‘As Left’ test data taken to the UUT tolerance
specifications.
15.3. Depending on the As‐left condition, the UUT ‘As Left’ data must be entered on the
Calibration Report as applicable (reference step 13).
16. Final: Calibration Completion / Data Submittal:
16.1. Input all remaining appropriate data in the UUT Calibration Report. Review all test data to
verify the UUT is within tolerance.
16.2. Complete the Calibration Data Report & Label as specified in ISO‐QSP‐20015.
16.3. Complete all documentation and review prior to submittal to Client.
16.4. Compile all Calibration Data Forms and attach NIST certificates for all traceable test
equipment used in the procedure.
16.5. Submit documentation for review and approval by Client.
17. End of Procedure
© COPYRIGHT 2018 ‐ 2021, CONFIDENTIAL & PROPRIETARY
INTEGRATED SERVICE SOLUTIONS, INC., AN ISO 9001:2015 REGISTERED COMPANY
1565 Bustard Road
Lansdale, PA 19446
Phone: 610‐287‐3433 Fax: 610‐287‐0233
Web: www.integratedservicesolutions.com
Document Type: Calibration Work Instructions Effective Date: 06 Aug 2018
TM Title: Mass Comparison Calibration [WHT‐CAL]
ID: ISO‐CWI‐3152 Revision: 6.00 Page: 21 Of 21
18. Revision History
Rev. Approvals
Date Description of Change
No. ERES‐Signature
M. Cabanas
0.00 11 Nov 2005 Initial Release of Draft Document for review NA
Developer
S. DeSmedt
QA Edit / See file
1.00 30 Dec 2005 New Release Review
M. Cabanas See file
Final Approval
S. DeSmedt
Added deviation from standard procedure Edit / Review See file
2.00 06 Oct 2006 (section 4.0) wording for ISO/IEC‐17025:2005
M. Cabanas
compliance. See file
Final Approval
M. Cabanas
Update to GLP processes per A2LA audit Edit / Review See file
3.00 28 Feb 2007
findings S. DeSmedt
Final Approval See file
S. DeSmedt
Added 12.9 for correction factor updating & Final Approval See file
4.00 17 May 2007
method. M. Cabanas
Edit / Review See file
Removed UL logos, updated address, and F.Aponte See File
updated references for General Safety Edit/Review
5.00 23 May 2014 Practices to current ISO‐QSP‐2117. Updated
L.Myles
the Uncertainty references to 17025 scope of See File
accreditation. Final Approval
Digitally signed
F.Aponte by Frances
Aponte
Edit/Review Date: 2018.08.06
09:25:57 -04'00'
6.00 06 Aug 2018 Updated ISO 9001:2015 reference.
Digitally signed by
Lisa Myles
L.Myles Reason: I approve
Final Approval this document
Date: 2018.08.06
09:32:13 -04'00'
This document when printed from the electronically secured & controlled TMS Program is an uncontrolled document.
© COPYRIGHT 2018 ‐ 2021, CONFIDENTIAL & PROPRIETARY
INTEGRATED SERVICE SOLUTIONS, INC., AN ISO 9001:2015 REGISTERED COMPANY