4.4 Calibration records
An essential element in the maintenance of measurement systems and the
operation of calibration procedures is the provision of full documentation.
This must give a full description of the measurement requirements throughout
the workplace, the instruments used, and the calibration system and procedures
operated. Individual calibration records for each instrument must be included
within this. This documentation is a necessary part of the quality manual,
although it may physically exist as a separate volume if this is more
convenient. An overriding constraint on the style in which the documentation is
presented is that it should be simple and easy to read. This is often greatly
facilitated by a copious use of appendices.
The starting point in the
documentation must be a statement of what measurement limits have been defined
for each measurement system documented. Such limits are established by
balancing the costs of improved accuracy against customer require[1]ments, and also
with regard to what overall quality level has been specified in the quality
manual. The technical procedures required for this, which involve assessing the
type and magnitude of relevant measurement errors, are described in Chapter 3.
It is customary to express the final measurement limit calculated as ลก2
standard devi[1]ations, i.e.
within 95% confidence limits (see Chapter 3 for an explanation of these terms).
The instruments specified for each
measurement situation must be listed next. This list must be accompanied by
full instructions about the proper use of the instruments concerned. These
instructions will include details about any environmental control or other
special precautions that must be taken to ensure that the instruments provide
measurements of sufficient accuracy to meet the measurement limits defined. The
proper training courses appropriate to plant personnel who will use the
instruments must be specified.
Having disposed of the question about what instruments are used, the
documentation must go on to cover the subject of calibration. Full calibration
is not applied to every measuring instrument used in a workplace because BS EN
ISO 9000 acknowledges that formal calibration procedures are not necessary for
some equipment where it is uneconomic or technically unnecessary because the
accuracy of the measurement involved has an insignificant effect on the overall
quality target for a product. However, any equipment that is excluded from
calibration procedures in this manner must be specified as such in the
documentation. Identification of equipment that is in this category is a matter
of informed judgement.
For instruments that are the
subject of formal calibration, the documentation must specify what standard
instruments are to be used for the purpose and define a formal procedure of
calibration. This procedure must include instructions for the storage and
handling of standard calibration instruments and specify the required
environmental conditions under which calibration is to be performed. Where a
calibration proce[1]dure for a
particular instrument uses published standard practices, it is sufficient to
include reference to that standard procedure in the documentation rather than
to repro[1]duce the whole
procedure. Whatever calibration system is established, a formal review
procedure must be defined in the documentation that ensures its continued
effective[1]ness at regular
intervals. The results of each review must also be documented in a formal way.
A standard format for the
recording of calibration results should be defined in the documentation. A
separate record must be kept for every instrument present in the workplace,
irrespective of whether the instrument is normally in use or is just kept as a
spare. A form similar to that shown in Figure 4.3 should be used that includes
details of the instrument’s description, the required calibration frequency,
the date of each calibration and the calibration results on each occasion.
Where appropriate, the documentation must also define the manner in which
calibration results are to be recorded on the instruments themselves.
The documentation must specify procedures that are to be followed if an
instru[1]ment is found to
be outside the calibration limits. This may involve adjustment, redrawing its
scale or withdrawing an instrument, depending upon the nature of the discrepancy
and the type of instrument involved. Instruments withdrawn will either be
repaired or scrapped. In the case of withdrawn instruments, a formal procedure
for marking them as such must be defined to prevent them being accidentally put
back into use.
Two other items must also be
covered by the calibration document. The traceability of the calibration system
back to national reference standards must be defined and supported by
calibration certificates (see section 4.3). Training procedures must also be
documented, specifying the particular training courses to be attended by
various personnel and what, if any, refresher courses are required.
All aspects of these documented calibration procedures will be given
consideration as part of the periodic audit of the quality control system that
calibration procedures are instigated to support. Whilst the basic
responsibility for choosing a suitable interval between calibration checks
rests with the engineers responsible for the instruments concerned, the quality
system auditor will require to see the results of tests that show that the
calibration interval has been chosen correctly and that instruments are not
going outside allowable measurement uncertainty limits between calibrations.
Particularly
important in such audits will be the existence of procedures that are
instigated in response to instruments found to be out of calibration. Evidence
that such procedures are effective in avoiding degradation in the quality
assurance function will also be required.
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