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EG.OP.09
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Validation of calibration instructions
Prepared by:
(Signature)
(E.g. Quality Management Supervisor)
(Title)
(Date)
Revised:
(Signature)
(E.g. Electronics Group Head)
(Title)
(Date)
Approved by:
(Signature)
(E.g. Director of the Organization)
(Title)
(Date)
EG.OP.09
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EG.OP.09
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1.
Title:
VALIDATION OF CALIBRATION INSTRUCTIONS.
2.
Purpose:
To define the set of procedures for the verification of the
adequacy of the results obtained by using a calibration
instruction adopted from a third party developer.
3.
Scope:
The scope of this procedure extends to all of the electrical
calibrations instructions adopted by the EG from other
developer sources.
4.
Definitions:
Verification operations: Initial visual inspection and
performance tests that serve to evaluate the functionality of the
instrument under calibration.
Calibration operations: Set of measurements or actions aimed
to verify the instrument performance in measurement,
functionality of operational modes and other characteristics of
the instrument under calibration.
Calibration result: Reported value that serves to evaluate the
fitness for purpose of the measurement results.
Uncertainty: A parameter associated with the result of a
measurement that characterises the dispersion of the values
that could be reasonably attributed to the measurand.
5.
References:
ISO GUM: 1995, Guide to the expression of uncertainty in
measurement.
EA-4/02, Expression of the uncertainty of measurement in
calibration, European Co-operation for accreditation,
December 1999.
VDI/VDE/DGQ/DKD 2622. Calibration of measuring
equipment for electrical quantities. Part 1 Fundamentals,
January 2001.
EG.OP.06
EG.OP.07
EG.OP.08
6.
Responsibilities: The EG Technical staff members are responsible for the
assessment of the validity of any electrical calibration
instruction adopted from external developer and implemented
in the EG.
The Technical Leader of EG has the responsibility of
reviewing the performance characteristics and estimation of
the uncertainty performed during instruction validation, as
well as to review and approving all the validated calibration
instructions.
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7.
Procedure:
7.1 Confirmation of identity and specificity:
The first step in the verification procedure starts from checking the
compliance of the instrument definition characteristics with those assumed
in the instruction. Instrument denomination, model, description of the main
features of operation shall match with those assumed in the procedure.
Otherwise, the procedure shall de modified by making proper adjustments.
A statement of the modifications made shall be included in a verification
report.
For example, the amount of working scales and their minimal and maximal
values specified in the instruction shall correspond to those observed in the
instrument. The uncertainties of the measurement stated in the instrument
technical specifications shall match with those assumed in the instruction.
7.2
Verification operations. The calibration instruction shall comprise initial
verification inspections to assess the instrument functionality before
proceeding to the operation. If such operations are not addressed in the
instruction, make annotation in the verification report, and relate the
modifications made to the instructions as to include such.
7.3
Calibration operations.
7.3.1 Primary measurements. Verify that the measurements corresponding
to evaluate the indication of each magnitude are defined as to cover
all of the working scales, reference values being selected as to
correspond to approximately 80 % of the maximal value of a given
scale. Each set of measurements shall include no less than 10
replicates. Annotate the results in the verification report.
7.3.2 Calibrator control. Verify that the instruction includes actions to
verify the trueness of the calibrator reference value. Follow the
instructions for IQC practice from EG.OP.06 and compare the
obtained value and uncertainty with those corresponding to the
calibrator nominal values in the verification report.
7.3.3 Uncertainty estimation: Calculate the uncertainty of the measured
values following the recommendations given in the operational
procedure EG.OP.08. The utility worksheet EG-UNC.xls can be
used for this purpose. Compare the results obtained with those
obtained by the instruction recommendations and make an
evaluation statement in the verification report. In case of
discrepancies, change the instruction as to obtain the values
calculated according to EG.OP.08 procedure.
7.3.4 Report of results and calibration certificate: Verify if the format for
reporting the results provided by the instruction under verification
corresponds to the conditions specified in EG.OP.07. Make
corrections if necessary and annotate such actions and the obtained
results in the verification report (EG.OF.16) that must be filed in
record EG.OR.16.
7.3.5 Additional actuators verification. Verify if actions are addressed to
check the proper functioning of other actuators in the instrument
which are relevant for its intended use (operation mode, threshold,
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sensitivity, etc.). Annotate the obtained results in the verification
report.
7.4
Statement of validity. Declare the validity of the verified instruction (and
modifications included) in the verification report.
8.
Records and forms:
9.
Utilities
EG.OR.16
EG.OF.04, EG.OF.16, EG.OF.08
EG-UNC.XLS
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