QM 11.2.10 Calibration

QM 11.2.
10 Calibration
Introduction
The company has established, documented and implemented a Calibration System for
monitoring and measuring equipment on site, which is maintained in order to ensure
conformity to product requirements in accordance with international standards and best
industry practice. The processes that contribute to meeting the requirements of these
standards have been determined.
Scope
The scope of the Calibration System includes all equipment used to measure, monitor
and manufacture product on site and activities conducted on site.
These requirements are aligned with the policies and objectives of the site and include
those of the SQF Code.
Procedure
The company maintains this procedure for the calibration of monitoring and measuring
equipment on site.
An inventory of all monitoring and measuring equipment critical to product quality and
safety or whose results can affect the conformity of product requirements is maintained
by the Engineering Manager. All equipment used for thermal processes is designed to
meet the specified process temperature gradient and holding parameters. Each piece of
equipment is labelled with a unique identification code which is also used to identify it on
all relevant documentation including calibration certificates.
All of the Measuring and monitoring Equipment is subject to regular servicing and
preventative maintenance as per the Preventative Maintenance Schedule for Critical
Equipment. The Equipment is also covered by maintenance contracts with the supplier.
Records of all work including maintenance, servicing and calibration of all equipment are
maintained and retained on site for a minimum of 3 years.
Document Reference QM 11.2.10 Calibration

Revision 1 1st May 2012
Owned by: Technical Manager 1
Authorised By: Managing Director
QM 11.2.10 Calibration
All measuring and monitoring equipment on site is used and maintained in accordance
with the instructions laid down in the manufacturer's handbooks/manuals. Operating and
maintenance instructions are displayed or held next to the equipment. Monitoring and
measuring equipment is safeguarded from maladjustment as only trained, authorized
personnel are permitted to use it. All authorised personnel are fully trained in the use of
equipment and records maintained in their personal training record.
All Measuring and monitoring equipment is protected from damage and deterioration.
This is normally by housing them away from the work environment or if this is not
possible, in a protective stainless steel case. Any equipment suffering damage or that
gives suspect results or malfunctions or is otherwise shown to be defective or unfit for
use is immediately removed from service. The item is promptly labelled or marked and is
not returned to service until it has been repaired, re-commissioned and revalidated as
appropriate. In the event of measuring equipment being found non compliant, the
equipment is adjusted, recalibrated and the Technical Manager is informed. The
Technical Manager addresses the disposition of potentially affected products when
measuring, test and inspection equipment is found to be out of calibration state. The
Technical Manager raises a Corrective Action Request and the validity of previous
measuring results are assessed and appropriate action taken regarding the product
affected. The details of the investigation and action taken are recorded on the corrective
action form.
All measuring and monitoring equipment is calibrated as per the Calibration Schedule at
intervals specified by the manufacturer and regulatory requirements against
measurement standards, traceable to national measurement standards. This is important
to provide traceability because the equipment is normally used to verify that the product
parameters meet specification. Where such standards do not exist, the basis for
configuration management and verification is recorded. Measurement devices forming
an integral part of equipment or are fixtures are calibrated in situ. The Calibration status
of all measuring and monitoring equipment is identified with a dated tag on the
equipment. This tag gives details of the last date of calibration and the period for which
the calibration is valid. Records of all calibrations are maintained in a calibration file
together with the current calibration certificate.

QM 11.2.10 Calibration
The Engineering Manager is responsible for establishing and implementation of the
calibration programme. Qualified service and calibration engineering contractors
calibrate measuring and monitoring equipment where applicable to provide an
independent verification of the equipment accuracy. For all equipment it is important
that their accuracy and reliability is confirmed as fit for purpose and so it is important
that calibrations are carried out across their operating range.
Instruments or equipment requiring calibration that is part of the Laboratory are

identified in the relevant Laboratory Procedure. Responsibility for ensuring the necessary
calibrations are carried out lies with the Laboratory Manager and records are retained.
When monitoring and measuring software is used in the process this software is
challenged prior to use and on an ongoing basis to ensure that it meets requirements and
is operating correctly. Results of the challenge test are recorded.
Responsibility
The Engineering Manager is responsible for establishing and implementation of the

calibration programme.
The Engineering Manager is responsible for maintaining calibration on all measuring and
monitoring equipment used in manufacturing areas.
The Laboratory Manager is responsible for calibration of laboratory equipment, weighing
balances, thermometers and for progressing inter-laboratory studies.
References
Calibration Record
Calibration Manuals
Manufacturer’s Handbooks/Manuals
Calibration Procedures
Calibration Schedule


QM 11.2.10 Calibration

Uploaded by

Copyright:

Available Formats

QM 11.2.10 Calibration

Uploaded by

Document Information

Original Description:

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

QM 11.2.10 Calibration

Uploaded by

Copyright:

Available Formats

QM 11.2.

Document Reference QM 11.2.10 Calibration

Document Reference QM 11.2.10 Calibration

Instruments or equipment requiring calibration that is part of the Laboratory are

The Engineering Manager is responsible for establishing and implementation of the

Document Reference QM 11.2.10 Calibration

You might also like